Tuesday, September 30, 2008

Cadbury Chocolate

Cadbury's Chocolate Safe in U.S.
Cadbury's Chocolate Recall Limited to Asia, Australia; Company Notes Melamine Risk

Sept. 29, 2008 -- The chocolate company Cadbury is temporarily taking certain chocolate products off the market -- but only in Asia and Australia.

In a news release, Cadbury calls the move a "precautionary step" because some Chinese dairy products are tainted with melamine, a chemical that artificially makes milk appear to have more protein.

Melamine can cause kidney diseases. In China, three babies have died and more than 54,000 have sought medical treatment related to melamine-tainted dairy products, according to the World Health Organization.

The FDA is following China's melamine problem. As of Sept. 25, FDA testing of milk-based products imported into the U.S. from China hadn't turned up any melamine contamination. The FDA warns against using Chinese-made infant formulas, which aren't approved for sale in the U.S.


Cadbury Chocolate

Cadbury is withdrawing a range of its chocolate products and Choclairs -- all made at Cadbury's Beijing plant -- from the market in China, Taiwan, Hong Kong, and Australia.

Cadbury products made at that plant are only exported to Taiwan, Hong Kong, and Australia.

Cadbury Eclairs are also temporarily coming off the market in Australia because they were made in Beijing. Cadbury states that a "small amount" of that product had also been exported to Christmas Island (an Australian territory in the Indian Ocean), and the South Pacific island nation of Nauru.

"No other products and countries are affected and consumers in all other countries can continue to enjoy our products with confidence," states Cadbury, adding that "Chinese dairy products are not used in any other Cadbury products we manufacture outside China."

Cadbury plans to get those products back on the market in Asia and Australia as soon as possible.

Other Melamine Recalls

Although Cadbury products sold in the U.S. are safe to eat, another sweet -- White Rabbit Candy -- is being recalled because it might be tainted with melamine.

QFCO Inc. of Burlingame, Calif., is recalling White Rabbit Candy, which was distributed in California, Georgia, Hawaii, Illinois, Minnesota, New York, Oregon, Texas, and Washington state. All packages have a logo of a white rabbit on the front with the words "White Rabbit." No illnesses have been linked to White Rabbit Candy.

You can return White Rabbit Candy to the place of purchase for a full refund. For more information on the White Rabbit Candy recall, call QFCO at 650-697-6633.they are warning this like.

Last week, the FDA also warned consumers to avoid seven Mr. Brown instant coffee and milk tea products made by the Taiwanese company King Car Food Industrial Co. Ltd because the nondairy creamer used to make those products may contain melamine.

Those products are:

Mr. Brown Mandheling Blend Instant Coffee (3-in-1)
Mr. Brown Arabica Instant Coffee (3-in-1)
Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
Mr. Brown French Vanilla Instant Coffee (3-in-1)

Mr. Brown Mandhling Blend Instant Coffee (2-in-1)

Mr. Brown Milk Tea (3-in-1)                                                                     

Sunday, September 28, 2008

Clinical Research list by City

Clinical Research by City 


Chennai

1 ABL BioTechnologies Ltd

Company that identifies & commercially extracts biochemicals from marine organisms; based in Chennai; activities: selling & licensing technology, producing biochemical intermediates, aquatic biotechnology research, contract research

Pharmaceutical Services Biotechnology


Andhra pradesh


1 Vimta Labs Limited

Providers of contract research & testing services based in Hyderabad; activities: clinical research, pre-clinical (animal) studies, clinical reference lab services, environmental assessments & analytical testing; has Fortune 500 clients

Clinical Research 

2 Actimus Biosciences Private Ltd

Full service CRO in Visakhapatnam (Andhra Pradesh) offering services like bioavailability / bioequivalence, protocol writing, clinical services, pharmacokinetic and statistical analysis, report preparation etc

Clinical Research 

3 Asian Clinical Trials

Contract / clinical research organisation based in Hyderabad; part of Suven Life Sciences; services include Phase II / III / IV clinical trials, post-marketing surveillance, clinical data management, regulatory affairs etc

Clinical Research 

4 GVK Biosciences Pvt Ltd

Company that provides contract research services to global pharmaceutical & biotechnology companies; based in Hyderabad; areas of activity include medicinal chemistry, process R&D, biology, clinical research, bioavailability/ bioequivalence etc

Clinical Research Pharmaceutical Services
 

5 Sipra Labs Private Ltd

Hyderabad-based pharmaceutical / analytical laboratory that provides specialised services in bio-availability, bio-equivalence, stability and method development studies; other services: formulation development, stability studies, clinical trials, etc

Clinical Research Laboratory Services


Haryana

1 CliniRx Research Private Ltd

Full-service contract clinical research company based in Gurgaon, Haryana; promoted by the JK Organization; services include feasibility studies, project management, pharmacovigilance, GCP training, biometrics etc

Clinical Research 

2 Kendle

Global CRO focusing on Phase I - IV clinical development expertise in the top five therapeutic areas: cardiology, oncology, antibiotics and antivirals, central nervous system, and arthritis/inflammation; India office is in Gurgaon

Clinical Research



Maharashtra

Mumbai

1 iGate Clinical Research International

Clinical trials management company headquartered in Mumbai; has a research-dedicated central laboratory fully accreditted by the College of American Pathologists; offers a complete range of phase II to IV clinical trial support services

Clinical Research 

2 Academy for Clinical Excellence

Institute in Mumbai providing training & education in clinical research; set up at the Bombay College of Pharmacy; offers certificate & post graduate diploma courses

Institutes Clinical Research 


3 Ace Biomed Private Ltd

Contract research organisation in Mumbai that provides a broad range of clinical research services like bioavailability and/or bioequivalence, selection of appropriate study design, writing of study protocol, designing of CRFs etc

Clinical Research 

4 Adroit Insights Lifesciences Pvt. Ltd

Clinical research specialists in Mumbai with broad expertise in Phase IV clinical trials; services include strategic planning and project management, site selection, investigator recruitment, clinical monitoring, medical management & writing, etc

Clinical Research 

5 ClinInvent Research Private Ltd

Clinical Research Organisation with end-to-end capabilities in clinical trial and data management; part of The Chatterjee Group Lifesciences (TCGLS) initiative; based in Mumbai

Clinical Research 

6 Khandelwal Laboratories Pvt Ltd (KLab)

Company in Mumbai, manufacturing and marketing speciality pharmaceutical formulations, niche APIs, chiral intermediates, & Novel Drug Delivery Systems; involved in clinical research in oncology, and contract manufacturing

Pharmaceuticals Clinical Research 


7 PharmaNet Development Group Inc

US-based group that conducts clinical research for the pharmaceutical, biotechnology, and medical device industries; has offices in Bangalore and Mumbai

Clinical Research 

8 PPD

US-based CRO that provides discovery, compound development and post-approval services as well as compound partnering programmes; has an office in Mumbai

Clinical Research Pharmaceutical Services 

9 SIRO Clinpharm Private Ltd

Contract research organisation based in Mumbai; offers services in clinical project management, clinical data management, medical monitoring and safety management, regulatory liaison and consulting, clinical trial supplies management etc

Clinical Research 

10 Thinq Pharma-CRO Ltd (formerly D&O Group)

Integrated pharmaceutical outsourcing company involved in contract research, contract manufacturing, clinical trials, clinical data management, biostatistics, medical writing, and BA/BE service activities; based in Mumbai

Clinical Research Pharmaceutical Services
 

Navi Mumbai

1 Accutest Research Laboratories (India) Private Ltd

Full service clinical research organisation with core strengths in bioavailability & bioequivalence studies, formulation development, clinical trials, and clinical data management; based in Navi Mumbai with offices in Pune, Ahmedabad and Japan

Clinical Research 

2 Reliance Clinical Research Services

Contract research organisation set up by the Reliance Group to provide world-class clinical research services to pharmaceutical, biotechnology and medical device companies; based in Navi Mumbai

Clinical Research

Gujarat 

 Ahmedabad

1 Lambda Therapeutic Research Ltd

Clinical research organisation based in Ahmedabad with another clinical facility in Mumbai; services: clinical pharmacology & medical affairs, clinical laboratory, clinical trials management, bioanalytical services, data management, biostatistics etc

Clinical Research 

2 Synchron Research Pvt. Ltd

Contract research organisation in Ahmedabad offering services to meet the needs of clients in the field of clinical registration of new pharmaceutical products and services from Phase I to Phase IV, including bioequivalence, bioavailability, etc

Clinical Research 

3 Veeda Clinical Research Ltd

Anglo / Indian clinical research organisation formed by the merger of Phase 1 Clinical Trials Unit in Plymouth, UK and ClinSearch Labs, an Indian CRO in Ahmedabad; offers full range of services for Phase I / II clinical research

Clinical Research

Vadodara

1 ARC -- Alembic Research Centre

Contract research services organisation in Vadodara that provides services in the domains of chemistry, formulations, pre-clinical bioequivalence / bioanalytical studies

Clinical Research


karnataka


1 Clinigene

Clinical research organisation in Bangalore that offers global biotechnology and pharmaceutical majors strong clinical trial, regulatory and laboratory capabilities for drug development; is a subsidiary of Biocon

Clinical Research 

2 ClinTec International

Privately owned contract research organisation based in the UK with a presence in over 30 countries worldwide; has experience in clinical trials in oncology, neurology, cardiovascular, psychiatry, infectious diseases etc; has an office in Bangalore

Clinical Research 

3 Clintrac International

Full-service contract research organisation based at the Vydehi Institute of Medical Sciences & Research Centre, Bangalore; has experience from Phase I to Phase IV clinical trials

Clinical Research
 

4 Lotus Labs

International CRO based in Bangalore; 100% subsidiary of Actavis hf, based in Iceland; expertise covers clinical services including biostudies, clinical trials Phase I to Phase IV, bioanalytical services, pharmacokinetics & statistical services

Clinical Research 

5 Manipal Acunova

Collaborative venture between the Manipal Education and Medical Group International India Pvt Ltd and AcuNova; offers services in clinical research like regulatory consulting, patient recruitment strategies, medical writing, etc; based in Bangalore

Clinical Research 

6 Omnicare Clinical Research

US-based Phase I to IV contract research organisation providing drug development services to pharmaceutical, biotechnology and medical device companies in 30 countries; has an office in Bangalore

Clinical Research 

7 PharmaNet Development Group Inc

US-based group that conducts clinical research for the pharmaceutical, biotechnology, and medical device industries; has offices in Bangalore and Mumbai

Clinical Research 

8 Quintiles India

Global CRO which offers services like clinical trial monitoring, project management, regulatory affairs, protocol development, drug safety, data management, centralised ECG etc; has offices in Mumbai, Bangalore and Ahmedabad

Clinical Research 

9 Triesta Sciences

Company in Bangalore that undertakes research in the identification, validation and development of cancer biomarkers and their integration with clinical drug development and molecular diagnostics

Clinical Research Laboratory Services 


New Delhi 


1 Neeman Medical International (NMI)

International clinical research services provider in North America, India & Costa Rica, & the only international site management organisation in the world; conducts clinical research in oncology, paediatrics, immune dysfunction, CNS, cardiology etc

Clinical Research

Saturday, September 27, 2008

LIST OF Code of Federal Regulations (CFR)

Code of Federal Regulations (CFR)

CFR TITLE 21

 21 CFR Part 1 
Cosmetics
Drugs
Exports
Food labeling
Imports
Labeling
Reporting and recordkeeping requirements

21 CFR Part 2 
Administrative practice and procedure
Cosmetics
Drugs
Foods

21 CFR Part 3 
Administrative practice and procedure
Biologics
Drugs
Medical devices

21 CFR Part 5 
Authority delegations (Government agencies)
Imports
Organization and functions (Government agencies)

21 CFR Part 7
Administrative practice and procedure
Consumer protection
Reporting and recordkeeping requirements

21 CFR Part 10 
Administrative practice and procedure
News media

21 CFR Part 11 
Administrative practice and procedure
Computer technology
Reporting and recordkeeping requirements

21 CFR Part 12 
Administrative practice and procedure
21 CFR Part 13 
Administrative practice and procedure

21 CFR Part 14 
Administrative practice and procedure
Advisory committees
Color additives
Drugs
Radiation protection

21 CFR Part 15 
Administrative practice and procedure

21 CFR Part 16 
Administrative practice and procedure

21 CFR Part 17 
Administrative practice and procedure
Penalties

21 CFR Part 19 
Conflict of interests

21 CFR Part 20 
Confidential business information
Courts
Freedom of information
Government employees

21 CFR Part 21 
Privacy

21 CFR Part 25 
Environmental impact statements
Foreign relations
Reporting and recordkeeping requirements

21 CFR Part 26 
Animal drugs
Biologics
Drugs
Exports
Imports

21 CFR Part 50 
Human research subjects
Prisoners
Reporting and recordkeeping requirements
Safety

21 CFR Part 54 
Biologics
Drugs
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 56 
Human research subjects
Reporting and recordkeeping requirements
Safety

21 CFR Part 58 
Laboratories
Reporting and recordkeeping requirements

21 CFR Part 60 
Administrative practice and procedure
Drugs
Food additives
Inventions and patents
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 70 
Color additives
Cosmetics
Drugs
Labeling
Packaging and containers

21 CFR Part 71 
Administrative practice and procedure
Color additives
Confidential business information
Cosmetics
Drugs
Reporting and recordkeeping requirements

21 CFR Part 73 
Color additives
Cosmetics
Drugs
Medical devices

21 CFR Part 74 
Color additives
Cosmetics
Drugs

21 CFR Part 80 
Color additives
Cosmetics
Drugs
Reporting and recordkeeping requirements

21 CFR Part 81 
Color additives
Cosmetics
Drugs

21 CFR Part 82 
Color additives
Cosmetics
Drugs

21 CFR Part 99 
Administrative practice and procedure
Biologics
Drugs
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 100 
Administrative practice and procedure
Food labeling
Food packaging
Foods
Intergovernmental relations

21 CFR Part 101 
Food labeling
Nutrition
Reporting and recordkeeping requirements

21 CFR Part 102 
Beverages
Food grades and standards
Food labeling
Frozen foods
Oils and fats
Onions
Potatoes
Seafood

21 CFR Part 104 
Food grades and standards
Frozen foods
Nutrition

21 CFR Part 105 
Dietary foods
Food grades and standards
Food labeling
Infants and children

21 CFR Part 106 
Food grades and standards
Infants and children
Nutrition
Reporting and recordkeeping requirements

21 CFR Part 107 
Food labeling
Infants and children
Nutrition
Reporting and recordkeeping requirements
Signs and symbols

21 CFR Part 108 
Administrative practice and procedure
Foods
Reporting and recordkeeping requirements

21 CFR Part 109 
Food packaging
Foods
Polychlorinated biphenyls (PCB's)

21 CFR Part 110 
Food packaging
Foods

21 CFR Part 113 
Food packaging
Foods
Reporting and recordkeeping requirements

21 CFR Part 114 
Food packaging
Foods
Reporting and recordkeeping requirements

21 CFR Part 115 
Eggs and egg products
Foods

21 CFR Part 119 
Dietary foods
Food additives
Foods

21 CFR Part 120 
Foods
Fruit juices
Imports
Reporting and recordkeeping requirements
Vegetable juices

21 CFR Part 129 
Beverages
Bottled water
Food packaging
Reporting and recordkeeping requirements

21 CFR Part 130 
Food additives
Food grades and standards

21 CFR Part 131 
Cream
Food grades and standards
Milk
Yogurt

21 CFR Part 133 
Cheese
Food grades and standards
Food labeling

21 CFR Part 135 
Food grades and standards
Food labeling
Frozen foods
Ice cream

21 CFR Part 136 
Bakery products
Food grades and standards

21 CFR Part 137 
Cereals (food)
Food grades and standards

21 CFR Part 139 
Food grades and standards

21 CFR Part 145 
Food grades and standards
Fruits

21 CFR Part 146 
Food grades and standards
Fruit juices

21 CFR Part 150 
Food grades and standards
Fruits

21 CFR Part 152 
Bakery products
Food grades and standards
Frozen foods
Fruits

21 CFR Part 155 
Food grades and standards
Vegetables

21 CFR Part 156 
Food grades and standards
Vegetable juices

21 CFR Part 158 
Food grades and standards
Frozen foods
Vegetables

21 CFR Part 160 
Eggs and egg products
Food grades and standards

21 CFR Part 161 
Food grades and standards
Frozen foods
Seafood

21 CFR Part 163 
Cacao products
Food grades and standards

21 CFR Part 164 
Food grades and standards
Nuts
Peanuts

21 CFR Part 165 
Beverages
Bottled water
Food grades and standards

21 CFR Part 166 
Food grades and standards
Food labeling
Margarine

21 CFR Part 168 
Food grades and standards
Sugar

21 CFR Part 169 
Food grades and standards
Oils and fats
Spices and flavorings

21 CFR Part 170 
Administrative practice and procedure
Food additives
Reporting and recordkeeping requirements

21 CFR Part 171 
Administrative practice and procedure
Food additives
21 CFR Part 172 
Food additives
Reporting and recordkeeping requirements

21 CFR Part 173 
Food additives

21 CFR Part 174 
Food additives
Food packaging

21 CFR Part 175 
Adhesives
Food additives
Food packaging

21 CFR Part 176 
Food additives
Food packaging

21 CFR Part 177 
Food additives
Food packaging

21 CFR Part 178 
Food additives
Food packaging

21 CFR Part 179 
Food additives
Food labeling
Food packaging
Radiation protection
Reporting and recordkeeping requirements
Signs and symbols

21 CFR Part 180 
Food additives

21 CFR Part 181 
Food additives
Food packaging

21 CFR Part 182 
Food additives
Food packaging
Spices and flavorings

21 CFR Part 184 
Food additives

21 CFR Part 186 
Food additives
Food packaging

21 CFR Part 189 
Food additives
Food packaging

21 CFR Part 190 
Food additives
Reporting and recordkeeping requirements

21 CFR Part 200 
Drugs
Prescription drugs

21 CFR Part 201 
Drugs
Labeling
Reporting and recordkeeping requirements

21 CFR Part 202 
Advertising
Prescription drugs

21 CFR Part 203 
Labeling
Prescription drugs
Reporting and recordkeeping requirements
Warehouses

21 CFR Part 205 
Intergovernmental relations
Prescription drugs
Reporting and recordkeeping requirements
Security measures
Warehouses

21 CFR Part 206 
Drugs

21 CFR Part 207 
Drugs
Reporting and recordkeeping requirements

21 CFR Part 208 
Labeling
Prescription drugs
Reporting and recordkeeping requirements

21 CFR Part 210 
Drugs
Packaging and containers

21 CFR Part 211 
Drugs
Labeling
Laboratories
Packaging and containers
Prescription drugs
Reporting and recordkeeping requirements
Warehouses

21 CFR Part 216 
Drugs
Prescription drugs

21 CFR Part 225 
Animal drugs
Animal feeds
Labeling
Packaging and containers
Reporting and recordkeeping requirements

21 CFR Part 226 
Animal drugs
Animal feeds
Labeling
Packaging and containers
Reporting and recordkeeping requirements

21 CFR Part 250 
Drugs

21 CFR Part 290 
Drugs
Labeling

21 CFR Part 299 
Drugs

21 CFR Part 300 
Drugs
Prescription drugs

21 CFR Part 310 
Administrative practice and procedure
Drugs
Labeling
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 312 
Drugs
Exports
Imports
Investigations
Labeling
Medical research
Reporting and recordkeeping requirements
Safety

21 CFR Part 314 
Administrative practice and procedure
Confidential business information
Drugs
Reporting and recordkeeping requirements

21 CFR Part 315 
Biologics
Drugs

21 CFR Part 316 
Administrative practice and procedure
Drugs
Reporting and recordkeeping requirements

21 CFR Part 320 
Drugs
Reporting and recordkeeping requirements

21 CFR Part 328 
Alcohol and alcoholic beverages
Labeling
Over-the-counter drugs

21 CFR Part 330 
Over-the-counter drugs

21 CFR Part 331 
Labeling
Over-the-counter drugs

21 CFR Part 332 
Labeling
Over-the-counter drugs

21 CFR Part 333 
Labeling
Over-the-counter drugs

21 CFR Part 335 
Labeling
Over-the-counter drugs

21 CFR Part 336 
Labeling
Over-the-counter drugs

21 CFR Part 338 
Labeling
Over-the-counter drugs

21 CFR Part 340 
Labeling
Over-the-counter drugs

21 CFR Part 341 
Labeling
Over-the-counter drugs

21 CFR Part 343 
Labeling
Over-the-counter drugs

21 CFR Part 344 
Labeling
Over-the-counter drugs

21 CFR Part 346 
Labeling
Over-the-counter drugs

21 CFR Part 347 
Labeling
Over-the-counter drugs

21 CFR Part 348 
Labeling
Over-the-counter drugs

21 CFR Part 349 
Labeling
Ophthalmic goods and services
Over-the-counter drugs

21 CFR Part 350 
Labeling
Over-the-counter drugs

21 CFR Part 352 
Labeling
Over-the-counter drugs

21 CFR Part 355 
Labeling
Over-the-counter drugs

21 CFR Part 357 
Labeling
Over-the-counter drugs
Reporting and recordkeeping requirements

21 CFR Part 358 
Labeling
Over-the-counter drugs

21 CFR Part 361 
Medical research
Prescription drugs
Radiation protection

21 CFR Part 369 
Labeling
Medical devices
Over-the-counter drugs

21 CFR Part 429 
Administrative practice and procedure
Drugs
Labeling
Packaging and containers
Reporting and recordkeeping requirements

21 CFR Part 500 
Animal drugs
Animal feeds
Cancer
Labeling
Packaging and containers
Polychlorinated biphenyls (PCB's)

21 CFR Part 501 
Animal foods
Labeling
Packaging and containers
Reporting and recordkeeping requirements

21 CFR Part 502 
Animal foods
Labeling

21 CFR Part 509 
Animal foods
Packaging and containers
Polychlorinated biphenyls (PCB's)

21 CFR Part 510 
Administrative practice and procedure
Animal drugs
Labeling
Reporting and recordkeeping requirements

21 CFR Part 511 
Animal drugs
Medical research
Reporting and recordkeeping requirements

21 CFR Part 514 
Administrative practice and procedure
Animal drugs
Confidential business information
Reporting and recordkeeping requirements

21 CFR Part 515 
Administrative practice and procedure
Animal drugs
Confidential business information
Reporting and recordkeeping requirements

21 CFR Part 520 
Animal drugs

21 CFR Part 522 
Animal drugs

21 CFR Part 524 
Animal drugs

21 CFR Part 526 
Animal drugs

21 CFR Part 529 
Animal drugs

21 CFR Part 530 
Administrative practice and procedure
Advertising
Animal drugs
Labeling
Reporting and recordkeeping requirements

21 CFR Part 556 
Animal drugs
Foods

21 CFR Part 558 
Animal drugs
Animal feeds

21 CFR Part 570 
Animal feeds
Animal foods
Food additives

21 CFR Part 571 
Administrative practice and procedure
Animal feeds
Animal foods
Food additives

21 CFR Part 573 
Animal feeds
Food additives

21 CFR Part 579 
Animal feeds
Animal foods
Radiation protection

21 CFR Part 582 
Animal feeds
Animal foods
Food additives

21 CFR Part 584 
Animal feeds
Food additives

21 CFR Part 589 
Animal feeds
Animal foods
Food additives

21 CFR Part 600 
Biologics
Reporting and recordkeeping requirements

21 CFR Part 601 
Administrative practice and procedure
Biologics
Confidential business information

21 CFR Part 606 
Blood
Labeling
Laboratories
Reporting and recordkeeping requirements

21 CFR Part 607 
Blood

21 CFR Part 610 
Biologics
Labeling
Reporting and recordkeeping requirements

21 CFR Part 630 
Blood
Reporting and recordkeeping requirements

21 CFR Part 640 
Blood
Labeling
Reporting and recordkeeping requirements

21 CFR Part 660 
Biologics
Labeling
Reporting and recordkeeping requirements

21 CFR Part 680 
Biologics
Blood
Reporting and recordkeeping requirements

21 CFR Part 700 
Cosmetics
Packaging and containers

21 CFR Part 701 
Cosmetics
Labeling
Reporting and recordkeeping requirements

21 CFR Part 710 
Cosmetics

21 CFR Part 720 
Confidential business information
Cosmetics

21 CFR Part 740 
Cosmetics
Labeling

21 CFR Part 800 
Administrative practice and procedure
Medical devices
Ophthalmic goods and services
Packaging and containers
Reporting and recordkeeping requirements

21 CFR Part 801 
Labeling
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 803 
Imports
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 806 
Imports
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 807 
Confidential business information
Imports
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 808 
Intergovernmental relations
Medical devices

21 CFR Part 809 
Labeling
Medical devices

21 CFR Part 810 
Administrative practice and procedure
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 812 
Health records
Medical devices
Medical research
Reporting and recordkeeping requirements

21 CFR Part 814 
Administrative practice and procedure
Confidential business information
Medical devices
Medical research
Reporting and recordkeeping requirements

21 CFR Part 820 
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 821 
Imports
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 822 
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 860 
Administrative practice and procedure
Medical devices

21 CFR Part 861 
Administrative practice and procedure
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 862 
Medical devices

21 CFR Part 864 
Blood
Medical devices
Packaging and containers

21 CFR Part 866 
Biologics
Laboratories
Medical devices

21 CFR Part 868 
Medical devices

21 CFR Part 870 
Medical devices


21 CFR Part 872 
Medical devices

21 CFR Part 874 
Medical devices

21 CFR Part 876 
Medical devices

21 CFR Part 878 
Medical devices

21 CFR Part 880 
Medical devices

21 CFR Part 882 
Medical devices

21 CFR Part 884 
Medical devices

21 CFR Part 886 
Medical devices
Ophthalmic goods and services

21 CFR Part 888 
Medical devices

21 CFR Part 890 
Medical devices

21 CFR Part 892 
Medical devices
Radiation protection
X-rays

21 CFR Part 895 
Administrative practice and procedure
Labeling
Medical devices

21 CFR Part 898 
Administrative practice and procedure
Medical devices

21 CFR Part 900 
Electronic products
Health facilities
Medical devices
Radiation protection
Reporting and recordkeeping requirements
X-rays

21 CFR Part 1000 
Electronic products
Radiation protection
Reporting and recordkeeping requirements
X-rays

21 CFR Part 1002 
Electronic products
Radiation protection
Reporting and recordkeeping requirements

21 CFR Part 1003 
Administrative practice and procedure
Electronic products
Radiation protection

21 CFR Part 1004 
Electronic products
Radiation protection

21 CFR Part 1005
Administrative practice and procedure
Electronic products
Imports
Radiation protection
Surety bonds

21 CFR Part 1010 
Administrative practice and procedure
Electronic products
Exports
Radiation protection

21 CFR Part 1020 
Electronic products
Medical devices
Radiation protection
Reporting and recordkeeping requirements
Television
X-rays

21 CFR Part 1030 
Electronic products
Microwave ovens
Radiation protection

21 CFR Part 1040 
Electronic products
Labeling
Lasers
Medical devices
Radiation protection
Reporting and recordkeeping requirements

21 CFR Part 1050 
Electronic products
Medical devices
Radiation protection

21 CFR Part 1210 
Administrative practice and procedure
Imports
Milk
Public health
Reporting and recordkeeping requirements

21 CFR Part 1220 
Administrative practice and procedure
Customs duties and inspection
Imports
Public health
Tea

21 CFR Part
Administrative practice and procedure
Imports
Labeling
Packaging and containers
Poison prevention

21 CFR Part 1240 
Communicable diseases
Public health
Travel restrictions
Water supply

21 CFR Part 1250 
Air carriers
Foods
Maritime carriers
Motor carriers
Public health
Railroads
Water supply

21 CFR Part 1270 
Communicable diseases
HIV/AIDS
Reporting and recordkeeping requirements

21 CFR Part 1271 
Biologics
Drugs
Human cells and tissue-based products
Medical devices
Reporting and recordkeeping requirements

21 CFR Part 1300 
Chemicals
Drug traffic control

21 CFR Part 1301 
Administrative practice and procedure
Drug traffic control
Security measures

21 CFR Part 1302 
Drug traffic control
Exports
Imports
Labeling
Packaging and containers

21 CFR Part 1303 
Administrative practice and procedure
Drug traffic control

21 CFR Part 1304 
Drug traffic control
Reporting and recordkeeping requirements

21 CFR Part 1305 
Drug traffic control

21 CFR Part 1306 
Drug traffic control
Prescription drugs

21 CFR Part 1307 
Drug traffic control

21 CFR Part 1308 
Administrative practice and procedure
Drug traffic control
Reporting and recordkeeping requirements

21 CFR Part 1309 
Administrative practice and procedure
Drug traffic control
Exports
Imports
Security measures

21 CFR Part 1310 
Drug traffic control
Exports
Imports
Reporting and recordkeeping requirements

21 CFR Part 1312 
Administrative practice and procedure
Drug traffic control
Exports
Imports
Reporting and recordkeeping requirements
21 CFR Part 1313 
Administrative practice and procedure
Drug traffic control
Exports
Imports
Reporting and recordkeeping requirements

21 CFR Part 1316 
Administrative practice and procedure
Authority delegations (Government agencies)
Drug traffic control
Research
Seizures and forfeitures

21 CFR Part 1401 
Freedom of information

21 CFR Part 1402 
Classified information

21 CFR Part 1403 
Accounting
Grant programs
Indians
Intergovernmental relations
Reporting and recordkeeping requirements

21 CFR Part 1404 
Administrative practice and procedure
Grant programs
Loan programs
Reporting and recordkeeping requirements

21 CFR Part 1405 
Administrative practice and procedure
Drug abuse
Grant programs
Loan programs
Reporting and recordkeeping requirements.

Sunday, September 21, 2008

Cell Phone - Male Infertility


Cell Phone Use Linked to Male Infertility

Hands-Free Calls May Expose Sperm to Radiation

Men, beware: Using a hands-free device with a cell phone may affect your fertility if you keep your phone close to your testicles, Cleveland Clinic researchers warn in the journal Fertility and Sterility.

Men who use these hands-free devices tend to carry their cell phones in their pants pocket or clipped to their belts at the waist while in talk mode. As a result, they may be exposing their testicles to damaging radiofrequency electromagnetic waves, explains Ashok Agarwal, PhD, head of the andrology laboratory and the director of the Center for Reproductive Medicine at the Glickman Urologoical and Kidney Institute at the Cleveland Clinic in Ohio.

"The Bluetooth devices, which many people are using these days because of health or safety concerns, may not be always so safe. There is a downside," he says.
Cell Phone Radiation Affects Sperm Quality

To arrive at their findings, researchers collected semen samples from 32 men and divided each man's sample into two parts. They placed half of the semen samples 2.5 centimeters away from a 850 MHz frequency cell phone in talk mode for one hour. Most cell phones used in the U.S. are 850-900 MHz. They chose this distance because it is the typical distance between the testes and the trouser pockets.

Previous research from the same group showed that radiofrequency electromagnetic waves emitted from cell phones can impair sperm quality, and the new study shows why this may occur. Semen exposed to radiofrequency electromagnetic waves emitted from cell phones had higher levels of damaging free radicals, lower sperm motility (the ability of the sperm to move and swim) and sperm viability (the percentage of live sperm), and possibly greater oxidative stress, the study shows. There were no significant differences in DNA damage between the exposed and unexposed groups.

"Our findings appear to be in line with other concerns that environmental factors such as toxins, pollutants, and materials used in farming play a role in male infertility," Agarwal says.

Further study is needed to validate the findings. "We will also test the effect [of radiofrequency electromagnetic waves emitted from cell phones] at other distances," he says. "We know the radiation impairs sperm quality at 2.5 centimeters, but we don't know if the effect will continue at 3, 4, or 5 centimeters," he says.

Future studies will determine if there is dangerous emission when the phone is in silent or standby mode.

"The emission may be smaller than when in talk mode, but could it still be harmful if it reaches the testes," he says.

Do Ask, Do Tell

Sami David, MD, a New York City-based reproductive endocrinologist, tells that he asks every male patient where they keep their cell phones and whether they use a hands-free device.

"You want it to stay far away from the testicles," he says. "I am more worried about the people that talk for three or four hours a day with the cell phone in their pocket than those who talk for shorter periods."

It's more than just cell phones. Other factors can affect male infertility, he says. "Men should not place their laptop on their laps due to the heat from the battery," he tells. "Jacuzzis, tub baths, toxins, and fumes can all play a role in male infertility and should be discussed."

Given the mechanism proposed by the new study, David says that antioxidants such as vitamins C and E may help reverse oxidative stress in sperm. He suggests all his male patients take certain antioxidants even when their sperm is normal.

Joe Farren, the assistant vice president for public affairs at CTIA, a wireless communications trade group, urges caution in interpreting the new findings, as well as other studies on how wireless phone usage affects health. "When you examine the weight of available scientific research that has been published and peer-reviewed and listen to leading health organizations around the world, you will find no association between wireless usage and adverse health effects," he tells. "We believe science has to guide this issue."

Saturday, September 13, 2008

Don’t Use Chinese Infant Formula

FDA: Don’t Use Chinese Infant Formula

Agency Warns of Possible Melamine Contamination in Infant Formula Made in China

Sept. 12, 2008 -- The FDA is warning parents and caregivers not to feed infant formula made in China to infants because of possible contamination with melamine, a chemical linked to tainted animal feed last year.

Infant formulas made in the U.S. are safe to use.

In China, one baby has died and others have developed kidney problems linked to melamine in Chinese infant formula, according to news reports.

Melamine artificially makes milk appear to have more protein; it can cause kidney diseases such as those seen in the Chinese infants, the FDA notes.

Infant formulas made in China shouldn't be on store shelves, regardless of melamine. The FDA requires all infant formula makers to register with the FDA and to meet certain standards; no Chinese companies have met those requirements.

The FDA issued the warning just in case any specialty markets serving the Asian community sell any Chinese infant formulas; the FDA is looking into that.

The following manufacturers have met the FDA's requirements for marketing infant formulas in the U.S.: Abbott Nutritionals, Mead Johnson Nutritionals, Nestle USA, PBM Nutritionals, Solus Products LLC, and SHS/Nutricia of Liverpool, England. Their products are safe and are not imported from China or made from materials from China, according to the FDA.

Sunday, September 7, 2008

Adverse Events

20 Drugs the FDA Is Watching

First New Quarterly Report IDs Drug Side Effects Under FDA Investigation

 
Sept. 5, 2008 -- The FDA is "evaluating" new adverse-event reports for 20 drugs, the agency announced today.

A 2007 federal law requires the FDA to disclose all its investigations into reports of possibly drug-related adverse events. Today's list is the first of this series of quarterly reports.

The list includes adverse events reported between Jan. 1 and March 31, 2008. FDA officials say it will be "weeks or months" before more recent reports are made.

All of the reports on the list come from the FDA's early-warning system for drugs already on the market. This Adverse Event Reporting System (AERS) collects reports from patients, hospitals, doctors, and drug companies about suspicious problems that might -- or might not -- be related to a medication.

Just because a drug is on the list doesn't mean it isn't safe -- or even that it caused the suspected problem. Nobody should stop taking a drug just because it's on the list, the FDA says.

"If a drug is listed, it means we have begun an analysis to see if there is a safety problem that requires further evaluation," Gerald Dal Pan, MD, MPH, director of the FDA office of surveillance and epidemiology, said at a news conference.

When that evaluation is done, the FDA will either issue further warnings or an all-clear, Dal Pan said.

Here's the list of drugs and the "adverse events" -- side effects -- reported to the AERS database:

(NOTE: See the attachment or send your email id I will be sending to you)

The report does not say how many people were affected by these possible drug reactions, nor does it give any indication of their severity.

"Our safety evaluators will look at the seriousness of the event, whether we are seeing greater numbers of a certain kind of event we should not expect, whether there is something new and not known about the drug, or whether this is something known but which may require refinement of our knowledge," Dal Pan said.

"This extends our commitment to keep the public and the health care community informed of what we are evaluating," Paul Seligman, MD, MPH, FDA associate director of safety policy and communication, said at the news conference.

(Note: The lists of drugs are not posted in FDA web page. So, See the attachment or send your email id I will be sending to you)

YOGA

Cleansing and Yoga

Even modern science now believes that disease, decay and degeneration are due to the presence of free radicals in the body. But how are the free radicals created?

Free radicals develop due to the accumulation of toxins in the body. Toxins, themselves, are a product of our lifestyle, our diet, the environment and our emotional patterns.

With our unregulated and undisciplined lifestyle, the kind of food we eat, the air we breathe, the water we drink and our emotional pulls and pressures, certain hormones are secreted that have a tendency to leave behind toxins.

The accumulation of toxins in our body is, therefore, natural. We CANNOT escape from this.

Yoga has a two pronged approach. In the long term it aims at developing attitudinal changes that prevent the build up of toxins through various practices and meditative techniques.

However, Yoga has very practical purification practices that aim at the detoxification of the body and mind. These detoxification techniques are a sort of cleansing that help the body rid itself of toxins.

These techniques, called Shatkarmas or Shatkriyas are extremely powerful in that they work on specific areas of the body that have the maximum impact upon our health.


Benefits of Cleansing:

• Helps to develop immunity by eliminating the toxins.

• Stimulates the mind and aids in removing lethargy (tamas).

• Washes the colon, sinus tracts, the stomach etc.

• Provides a massaging effect to the areas applied thereby stimulating the effective working of the Organs.

• Stimulates vitality and helps in retardation of ageing.

• One's capacity to think, digest, taste, feel express etc. increases and a greater awareness develops.


Cleansing Methods: What are they?

 Nasal Cleansing (Neti)
 Abdomen
 Colon
 Teeth
 Tongue
 Skin cleansing


NOTE: write your comment and questions.

Friday, September 5, 2008

Know about Mercury in Fish

What You Need to Know about Mercury in Fish and Shellfish

2004 EPA and FDA Advice for:
Women Who Might Become Pregnant
Women Who are Pregnant
Nursing Mothers
Young Children

Fish and shellfish are an important part of a healthy diet. Fish and shellfish contain high-quality protein and other essential nutrients, are low in saturated fat, and contain omega-3 fatty acids. A well-balanced diet that includes a variety of fish and shellfish can contribute to heart health and children's proper growth and development. So, women and young children in particular should include fish or shellfish in their diets due to the many nutritional benefits.

However, nearly all fish and shellfish contain traces of mercury. For most people, the risk from mercury by eating fish and shellfish is not a health concern. Yet, some fish and shellfish contain higher levels of mercury that may harm an unborn baby or young child's developing nervous system. The risks from mercury in fish and shellfish depend on the amount of fish and shellfish eaten and the levels of mercury in the fish and shellfish. Therefore, the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) are advising women who may become pregnant, pregnant women, nursing mothers, and young children to avoid some types of fish and eat fish and shellfish that are lower in mercury.

By following these 3 recommendations for selecting and eating fish or shellfish, women and young children will receive the benefits of eating fish and shellfish and be confident that they have reduced their exposure to the harmful effects of mercury.

1. Do not eat Shark, Swordfish, King Mackerel, or Tilefish because they contain high levels of mercury.
2. Eat up to 12 ounces (2 average meals) a week of a variety of fish and shellfish that are lower in mercury.
Five of the most commonly eaten fish that are low in mercury are shrimp, canned light tuna, salmon, pollock, and catfish.
Another commonly eaten fish, albacore ("white") tuna has more mercury than canned light tuna. So, when choosing your two meals of fish and shellfish, you may eat up to 6 ounces (one average meal) of albacore tuna per week.

3. Check local advisories about the safety of fish caught by family and friends in your local lakes, rivers, and coastal areas. If no advice is available, eat up to 6 ounces (one average meal) per week of fish you catch from local waters, but don't consume any other fish during that week.

Follow these same recommendations when feeding fish and shellfish to your young child, but serve smaller portions.

Know About Eating Fish


What You Need to Know About Eating Fish


With concerns about mercury levels in fish -- a usually healthful food, how much fish should pregnant women eat? What other options provide the same health benefits as fish? 

Follow these guidelines to stay healthy.
By Jeanie Lerche Davis
committee Feature
Reviewed by Louise Chang, MD

Fish and shellfish have gained star status on the dinner menu. Several medical groups now advocate tuna, salmon, and their fishy (and shellfish) cousins as important to a heart-healthy and overall healthy diet.

But for women, the choice has been less clear. The concern: Are fish and shellfish safe -- if pregnancy and children are in the picture? Could mercury in fish put an unborn, newborn, or young child at risk? Should pregnant women eat fish?

Various reports have turned up conflicting results -- some indicating risk, others pooh-poohing all the worry. To clarify this murky issue, committee turned to some of the nation's experts.

"[Pregnant] women should be cautious because their unborn fetus is very sensitive to toxicity from mercury," says Robert Goyer, MD, professor emeritus and chairman of pathology at University of Western Ontario. Goyer participated in a National Academy of Sciences (NAS) study evaluating the credibility of the EPA's mercury studies.

"We came up with the same results the EPA did," Goyer tells committee. "We don't know which stage of fetal development is more critical -- whether it's the third trimester or the moment of conception, or if it's continuous exposure to mercury during pregnancy. But all this has been factored together in the EPA/FDA advisory."
Government's Advice to Pregnant Women

In their statement issued last year the Environmental Protection Agency (EPA) and FDA - for the first time -- cited the health benefits of fish.

"Fish and shellfish contain high quality protein and other essential nutrients, are low in saturated fat, and contain omega-3 fatty acids," says their joint statement. "A well-balanced diet that includes a variety of fish and shellfish can contribute to heart health and children's proper growth and development. Thus, women and young children in particular should include fish or shellfish in their diets due to the many nutritional benefits."

However, mercury may be harmful to an unborn child or a young child. Mercury may have damaging effects to a child's developing brain.

"It may be prudent to modify your diet if you are: planning to become pregnant; pregnant; nursing; or a young child," the EPA statement adds.

 

The EPA and FDA advise pregnant women, young women who may become pregnant, or women who are nursing:
Do not eat: Shark, swordfish, king mackerel, or tilefish because they contain high levels of mercury.
Eat up to 12 ounces a week: Fish and shellfish varieties that are lower in mercury. These include shrimp, canned light tuna, salmon, pollock, and catfish. (An average can of tuna is 6 ounces.)
Buy canned tuna carefully. Light tuna has less mercury than albacore ("white") tuna. However, up to 6 ounces (one average meal) of albacore tuna per week is safe.
Check local fish advisories: Locally caught fish should be checked with local health departments. If no advice is available, eat up to 6 ounces (one average meal) per week of fish you catch from local waters, but don't consume any other fish during that week.
Apply these guidelines to young children: They can eat these low-mercury fish and shellfish. However, feed children smaller portions.

Also:
Fish sticks: Frozen fish sticks and fast-food fish sandwiches are commonly made from fish that are low in mercury.
Tuna steaks generally contain higher levels of mercury than canned light tuna.


Undisputed Benefits of Omega-3 Fats

The omega-3 fats in many fish and seafood are known to lower risk of heart disease and benefit the brain. The American Heart Association advises at least two servings a week of fish like mackerel, lake trout, herring, sardines, albacore tuna, and salmon because of these healthy fats. However, the following people should take care to consume fish sources of omega-3 fats with lower mercury content: women who wish to become pregnant or are now pregnant; women who are nursing; and young children.

In a developing fetus, omega-3 fats promote brain, eye, and motor development, the EPA notes.

Pregnant Women and Big Fish Risks

The mercury in fish and seafood is indeed the big concern -- although there are other toxins like PCBs that have warranted some worry. Mercury exists naturally in the environment, but more is released into air, land, and water by trash burning, fossil fuel combustion in factories, mining, and the dumping of sewage sludge in croplands.

Once mercury gets into surface water, it quickly makes its way through the aquatic food chain. In smaller organisms, there is usually an insignificant amount of mercury. But as fish get older or as bigger fish eat smaller ones, the mercury content begins to build.

Fish at the top of the food chain - pike, bass, older or large tuna, tilefish, king mackerel, shark, and swordfish - tend to have higher levels of mercury, from one to 1 million times greater than the amount in the waters, according to the EPA.

If you're eating a lot of fish, mercury accumulates in your bloodstream over time. While the body naturally gets rid of mercury, it may take a year for the levels to drop significantly. Thus, it may be present in a woman even before she becomes pregnant. This is the reason why women who are trying to become pregnant - or pregnant women -- should also avoid eating certain types of fish.

 
For women wanting to switch to other omega-3 sources, there are options, says Julie Redfern, RD, a registered dietitian in obstetrics at Brigham & Women's Hospital in Boston. She has counseled thousands of pregnant or soon-to-be-pregnant women.

"It's one of those questions that comes up almost every day … mercury and fish," Redfern tells committee."Some women are very well-read, and they say they are not going to eat any fish. Others say, 'I love fish,' and want to know what's safe. I give them the FDA's list of safe fish. I ask them what fish they usually eat, and look for it on the list. I also talk to them about canned tuna, about the different kinds of tuna - and what's on the 'avoid' list."

Overall, she says, "I feel very comfortable reassuring them that if they keep it to the 'safe' fish -- and eat no more than two servings a week -- they'll be fine."

But, flaxseed oil, walnuts, canola oil, wheat germ, and omega-3-fortified eggs are excellent food sources for these fats. Also, a couple of new prenatal vitamins - and a 200 mg supplement - contain an algae-derived form of omega-3 fats, she adds.

"These are from vegetable plants, so the fats are not quite the same … the body converts them more slowly. But if someone doesn't want fish, it still works."

Redfern identifies with those who love fish and hate to cast it from their diet entirely. "With them, I advise making sure you're not eating as much as in you once did. You don't to want frighten them, make them not eat fish at all."

The bottom line: Fish contain beneficial protein and fats, but if you want to become pregnant, are already pregnant, or are nursing, follow the EPA and FDA advice.
Do not eat Shark, Swordfish, King Mackerel, or Tilefish because they contain high levels of mercury.
Eat up to 12 ounces (2 average meals) a week of fish and shellfish that are lower in mercury, such as shrimp, salmon, catfish, Pollock and canned light tuna.
Check local advisories about the safety of fish caught by family and friends in your local lakes, rivers, and coastal areas.

Arthritis

Deaths Heighten Arthritis Drugs Warning

Enbrel, Humira, Remicade, and Cimzia to Get Stronger Warning About Fungal Infections
By Miranda Hitti

MD Health News
Reviewed by Louise Chang, MD

Sept. 4, 2008 -- The FDA today ordered stronger warnings about the risk of potentially deadly fungal infections, especially one called histoplasmosis, in people taking the drugs Cimzia, Enbrel, Humira, and Remicade, which are called TNF blockers.

The FDA has received 240 reports of patients taking TNF blockers who developed histoplasmosis, a fungal infection that starts as a respiratory infection and can spread throughout the body.

Of those 240 patients, 45 patients died, including at least 12 who hadn't been diagnosed with histoplasmosis right away, according to Jeffrey Siegel, MD, clinical team leader in the division of anesthesia, analgesia, and rheumatology products at the FDA's Center for Drug Evaluation and Research. The histoplasmosis patients ranged in age from 8 to 86 years; none of the deaths involved children.

The FDA wants patients and doctors to watch for signs and symptoms of histoplasmosis, including persistent fever, cough, shortness of breath, and fatigue. 

"Our advice to patients is don't hesitate to call your doctor if you see these signs and symptoms that are related to these types of infection," Siegel said at a news conference today.

Known Risk of Histoplasmosis

It's not news that TNF blockers can raise the risk of infection, including histoplasmosis and other fungal infections. The FDA and doctors already knew about that. Today's FDA action is about how that risk is noted on the drugs' labels.

TNF blockers suppress the immune system and are used to treat conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.

All TNF blockers already have "black box" warnings, the FDA's sternest warning, about infection risk. And Cimzia, Remicade, and Humira -- but not Enbrel -- already mention the risk of invasive fungal infections in their black-box warnings.

But no TNF blockers single out histoplasmosis in their black box warning, and the FDA wants that to change.

Stronger Warning for Fungal Infections


"We're going to make sure that all the boxed warnings state clearly that fungal infections -- including in particular histoplasmosis, which is the main one that has come to our attention as having been missed in a number of cases -- will be highlighted," says Siegel.

He says the strengthened warnings will also encourage doctors to identify at-risk patients (including people who live in the Ohio and Mississippi River valleys, where histoplasmosis is more common), and to consider starting certain patients on antifungal therapy if it's likely that they have histoplasmosis -- even if that hasn't been confirmed by lab tests.

Antifungal treatment is effective but can be "highly toxic," says Siegel, warning that the decision to start such antifungal treatment is "not to be taken lightly."

Histoplasmosis can be "particularly difficult to diagnose," says Siegel, adding that histoplasmosis tests sometimes miss histoplasmosis.


Drug Companies Respond

Seigel says all drug companies that make TNF blockers are cooperating with the FDA.

MD contacted the makers of all four TNF blockers for their comments. Humira is made by the drug company Abbott. Cimzia is made by the drug company UCB. Remicade is made by the drug company Centocor. Enbrel is marketed by the drug companies Amgen and Wyeth. .

Laureen Cassidy, a spokeswoman for Abbott, tells MD that Abbott "will comply with the FDA's request." Cassidy notes that Humira's black-box warning already mentions fungal infections and refers to a bolded warning elsewhere in Humira's label about histoplasmosis, and that the infection is rare but can go unrecognized.

Sonia Fiorenza, director of corporate communications for Amgen, told MD via email that Amgen will work with the FDA to "finalize and communicate revised product labeling for Enbrel to both physicians and patients."

Bert Kelly, spokesman for UCB, says his company will "certainly" work with the FDA. "We had very strong safety language; if the FDA thinks there needs to be some stronger language, we'll work to get that done," Kelly tells MD.

Centocor did not provide comments to MD in time for publication.

  FDA news & report,  
  Dr.U.SARATHBABU,  

FDA OKs Cymbalta

FDA OKs Cymbalta for Fibromyalgia

Cymbalta is the First Antidepressant Approved to Treat Fibromyalgia
By Miranda Hitti

MD Health News
Reviewed by Louise Chang, MD

June 16, 2008 -- The FDA has approved the drug Cymbalta to treat fibromyalgia.

That makes Cymbalta the first antidepressant approved to treat fibromyalgia, which is a chronic disorder of the muscles and related soft tissue, including ligaments and tendons. Its main symptoms are muscle pain, fatigue, sleep disturbances, and tender points at certain points of the body.

Besides fibromyalgia and depression, Cymbalta is also approved to treat generalized anxiety disorder and diabetic peripheral neuropathic pain, a diabetes-related pain condition, in adults.

Cymbalta belongs to a class of drugs called serotonin and norepinephrine reuptake inhibitors (SNRIs).

The FDA approved Cymbalta for fibromyalgia based on two clinical trials that together included 874 fibromyalgia patients, according to Lilly.

For three months, the patients either took Cymbalta or a placebo. Cymbalta trumped the placebo at pain reduction and overall improvement.

Compared to patients taking the placebo, Cymbalta patients were more likely to experience nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating, and agitation.

Cymbalta is the second drug approved by the FDA to treat fibromyalgia. Nearly a year ago, the FDA approved Lyrica as the first drug treatment for fibromyalgia. Lyrica also treats nerve pain caused by shingles and diabetes, as well as reducing some forms of epileptic seizures.


  FDA news & report,  
  Dr.U.SARATHBABU,  

Wednesday, September 3, 2008

ayurveda in india

Ayurveda in India
Ayurveda in India—the science of life, the origin of most forms of natural and alternative medicine—has its mention in one of the oldest (about 6,000 years) philosophical texts of the world, the Rig Veda. The Sutrasthana of Charaka Samhita, a much referred ayurvedic text, says; "The three—body, mind and soul—are like a tripod, the world stand by their combination; in them everything abides. It is the subject matter of ayurveda for which the teachings of ayurveda have been revealed." (1.46-47)

In its broader scope, ayurveda in India has always sought to prepare mankind for the realization of the full potential of its self through a psychosomatic integration. A comprehensive health care is what this natural and alternative medicine prescribes for the ultimate self-realization.

"Life (ayu) is the combination (samyoga) of body, senses, mind and reincarnating soul. Ayurveda is the most sacred science of life, beneficial to humans both in this world and the world beyond."
—Charaka Samhita, Sutrasthana, 1.42-43.

The verses of Rig Veda, the earliest source of ayurveda, refer to panchamahabhut (five basic elements of the entire creation), and the three doshas or primary forces of prana or vata (air), agni or pitta (fire) and soma or kapha (water and earth) as comprising the basic principles of ayurveda. One branch of Indian philosophy—Sankhya states that there are 24 elements, all of which constitute the foundation of the gross world: earth, water, fire, air and ether. These five elements in different combinations constitute the three body types/doshas—vata dosha (air and ether), pitta dosha (fire) and kapha dosha (earth and water). The panchamahabhut and the dosha theories are the guiding factors of ayurveda as a therapeutic science. The Rig Veda also mentions organ transplants and herbal remedies called soma with properties of elixir.

This science or knowledge of healing, as mentioned in the Rig Veda, was revealed to Rishi Bharadvaja from the great Cosmic Intelligence. The knowledge consists of three aspects known as the Tri-Sutras of ayurveda, which are—etiology or the science of the causes of disease, symptomatology or the study and interpretation of symptoms and medication and herbal remedies.
Approximately, during 4,000 to 3,000 BC, Sam Veda and Yajur Veda, the second and third Vedas came into being. Chanting of mantras and performance of rituals were, respectively, dealt in these two Vedas. And, during 3,000 to 2,000 BC Atharva the fourth Veda was authored, of which ayurveda is an upaveda (subsection). Though it had been practiced all along, it was around this time that ayurveda in India, was codified from the oral tradition to book form, as an independent science. It enlists eight branches/divisions of ayurveda: Kayachikitsa (Internal Medicine), Shalakya Tantra (surgery and treatment of head and neck, Ophthalmology and Otolaryngology), Shalya Tantra (Surgery), Agada Tantra (Toxicology), Bhuta Vidya (Psychiatry), Kaumarabhritya (Pediatrics), Rasayana (science of rejuvenation or anti-aging), and Vajikarana (the science of fertility). The oldest treatise available on this codified version is Atreya Samhita.
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The most fascinating aspect of ayurveda is, it was using almost all methods of healing like lifestyle regimen, yoga, aroma, meditation, gems, amulets, herbs, diet, jyotishi (astrology), color and surgery etc. in treating patients. Though ayurveda came into being as an independent upaveda of Atharva Veda, it has close links with other Vedas also. The Yajur Veda, which recommends rituals to pacify the panchamahabhuts in a view to heal both the Cosmic Being and the individual soul, is related to ayurveda in its principles and regulations of lifestyle. The upaveda called Dhanur Veda or the martial arts and ayurveda both refer to each other in the treatment of marmas or sensitive points in the body. Ayurveda recommends specific ayurvedic massages, exercises and bodywork for this purpose.


Around 15,00 BC ayurveda was delineated into to two distinct schools: Atreya—The School of Physicians, and Dhanvantari—The School of Surgeons. This made ayurveda a more systematically classified medical science, hereafter. Dhanvantari, who is considered to be a reincarnation of Lord Vishnu, was the guiding sage of ayurveda. He made this science of health and longevity popular and widely acceptable. In fact, these two schools of thought led to the writing of two major books on ayurveda—Charaka Samhita and Susruta Samhita.

These two Samhitas were written in the early part of 1000 BC. The great sage- physician Charaka authored Charaka Samhita revising and supplementing the text written by Atreya, which has remained the most referred ayurvedic text on internal medicine till date. Susruta, following the Dhanvantari School of Thought, wrote Susruta Samhita, comprising the knowledge about prosthetic surgery to replace limbs, cosmetic surgery, caesarian operations and even brain surgery. He is famed for his innovation of cosmetic surgery on nose or rhinoplasty. Around 500 AD, Vagbhatt compiled the third major treatise on ayurveda, Astanga Hridaya. It contained knowledge comprising the two schools of ayurveda.

From 500 AD to 1900 AD, sixteen major Nighantus or supplementary texts on ayurveda like Dhanvantari Bhavaprakasha, Raja and Shaligram among others were written incorporating new drugs, expansion in applications, discarding of old drugs and identification of substitutes. These texts mention about 1814 varieties of plants in vogue.

Evidences show that ayurveda had nurtured almost all the medical systems of the world. The Egyptians learnt about ayurveda long before the invasion of Alexander in the 4th century BC through their sea-trade with India. Greeks and Romans come to know about it after the famous invasion. The Unani form of medical tradition came out of this interaction. In the early part of the first millennium ayurveda spread to the East through Buddhism and greatly influenced the Tibetan and Chinese system of medicine and herbology. Around 323 BC, Nagarjuna, the great monastic of Mahayana Buddhism and an authority on ayurveda had written a review on Susruta Samhita. In 800 AD ayurveda was translated into Arabic. The two Islamic physicians Avicenna and Razi Serapion, who helped form the European tradition of medicine, strictly followed ayurveda. Even, Paracelsus, considered to be the father of the modern western medicine toed the line of ayurveda, as well.
In the postmodern age, the popularity of this vibrant tradition of ayurveda lies in its, subtle yet scientific, approach to heal a person in its totality. It aims, not only at healing the body, but also the mind and spirit, at one go. Its unique understanding of the similarities of natural law and the working of human body, as well as its holistic treatment methods, help it to strike a balance between the two. This gives ayurveda an edge over other healing systems. Perhaps that's the reason behind ayurveda being the longest unbroken medical tradition in the world, today.
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Charaka Samhita is considered to be the most ancient and authoritative writing on ayurveda available today. It also explains the logic and philosophy on which this system of medicine is based. The detailed biography of the composer of this treatise—that is, sage Charaka—is not known to the posterity. Interestingly, it is not an original writing of a single person rather like all Vedic knowledge it is a continuation and renewal of that ancient knowledge system. In fact, Charaka had redacted the Agnivesa Samhita (an edited version of Atreya Samhita). The available form of Charaka Samhita was again worked upon by Drdhabala (living in about 400 AD) long after sage Charaka.

According to Charaka, science is dependent upon yukti—a quality of the intellect that enables it to perceive phenomena brought into existence by a multiplicity of causes. Thus, it's not surprising that much of the treatise of Charaka Samhita is in the form of a symposium wherein groups of ayurvedic scholars take up a series of topics for discussion. This gives indication that the science of ayurveda is a product of constant verification, fine-tuning and authentication by an active community of physicians. The samhita mentions about the gradual development of the fetus within the womb in minutes that equals the modern medical version in accuracy.

The language is Sanskrit and is written in verse form. The style is in keeping with the Vedic oral tradition of conserving knowledge. The samhita contains 8,400 metrical verses.

Charaka followed the Atreya School of Physicians, which predominantly deals with treatments through internal and external application of medicine. Though the samhita contains all the theoretical knowledge of ayurveda it's focus is on healing the body, mind and soul of a patient in the minimum invasive manner that's Kayachikitsa. Hence, he placed great emphasis on the diagnostic part of the treatment. So much so that he classified everything from solar calendar to topography to the timing of the birth of a child. He identified eight stages of a disease from its inception to the culmination. Charaka also laid great emphasis on the timing and manner of the collection of medicinal plants.
Charaka sought to correct the element of fire or the digestive function in a body. It sought to alter the chemical processes in the cells by purification methods and medicinal application. From a greater perspective Charaka laid emphasis for health and longevity to strike a balance between one's corporeal and spiritual being. That is the reason why Charaka went so detail into the diagnosis of a disease's origin.
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Susruta wrote his samhita, the most authentic text on the practice of ayurvedic surgery around the sixth century BC Susruta is, also, renowned as the father of plastic surgery. He represents the Dhanvantari School of surgeons. His samhita discussed in minute details on how to perform prosthetic surgery to replace limbs, cosmetic surgery on nose and on other parts of the body, cesarean operations, setting of compound fractures, and even brain surgery. Susruta's original work seems to have been revised and supplemented by Nagarjuna between the third and fourth centuries AD.

This branch of medicine is believed to have arisen in part from the exigencies of dealing with the effects of war. Epic Ramayana, mentions remarkable feats of surgery having taken place in the past. We have reference to the transplantation of an eyeball and a head in epics.

The style Susruta Samhita is both prose and poetry with poetry being the greater portion. This work, also, is said to be a redaction of oral material passed down verbally from generation to generation.

This work is unique in that it discusses blood in terms of the fourth doshic principle. This work is the first to enumerate and discuss the pitta subtypes. Susruta details about 125 surgical instruments used by him mostly made of stones,wood and other such natural materials. The Susruta Samhita presents many innovations in ayurvedic surgery. Use of shalaka—meaning foreign body (here, rods or a probe etc.) is mentioned by Susruta. Some of the classifications found in the Susruta Samhita are not even traced by the modern medical science. It described five types of pterygium, and the prognosis it made about glaucoma has not been improved since. In fact he is the first surgeon in medical history who systematically and elaborately dealt with anatomical structure of eye.
Susruta has discussed about 72 diseases of the eye. He has stipulated drug therapy for various types of conjunctivitis and glaucoma along with surgical procedures of the removal of cataract, pterygium, diseases of ear, nose and throat.

The Susruta Samhita, besides being the most authentic text on practice and theory of surgery, is also the most commonly quoted text on health.
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Astanga Hridaya is accepted as the third major treatise on ayurveda. Around 500 AD, Vagbhatt compiled this samhita. It contained knowledge comprising the two schools of ayurveda—the school of surgery and the school of physicians.

There is another similar work called the Astanga Sangraha belonging to the same period. It is slightly bigger in size than the Astanga Hridaya, and is written in verse form whereas the later text was in prose form. It is believed either there are two works by a person or two persons with the same name. However, both the works came into being after the Charaka and Susruta Samhitas.

The Astanga Hridaya primarily deals with kayachikitsa besides, discussing in detail about various surgical treatments. The kapha subtypes are first listed and described in this samhita, completing exhaustive explanation of vata, pitta, kapha with their five subtypes.

Astanga Hridaya seems to emphasize on the physiological aspect of the body rather than the spiritual aspects of it like its counterparts—Charaka and Susruta Samhitas. Despite that, the quality and range of its discussions about ayurveda makes it a work to reckon with.

proud to be indian

I am an INDIAN.All the below listed statements are all true facts ! Feel proud to be an Indian !
Q. Who is the creator of Pentium chip (needs no introduction as 90% of the today's computers run on it)?
A. Vinod Dahm
Q. Who is the founder and creator of Hotmail (Hotmail is world's No.1 web based email program)?
A. Sabeer Bhatia
Q. We Indians are the wealthiest among all ethnic groups in America, even faring better than the whites and the natives.
There are 3.22 millions of Indians in USA (1.5% of population). YET,
*38% of doctors in USA are Indians.
* 12% scientists in USA are Indians.
* 36% of NASA scientists are Indians.
* 34% of Microsoft employees are Indians.
* 28% of IBM employees are Indians.
* 17% of INTEL scientists are Indians.
* 13% of XEROX employees are! Indians.
Some of the following facts may be known to you. These facts were recently published in a German magazine, which deals withWORLD HISTORY FACTS ABOUT INDIA.
1. India never invaded any country in her last 1000 years of history.
2. India invented the Number system. Zero was invented by Aryabhatta.
3. The world's first University was established in Takshila in 700BC. More than 10,500 students from all over the world studied more than 60 subjects. The University of Nalanda built in the 4 th century BC was one of the greatest achievements of ancient India in the field of education.
4. According to the Forbes magazine, Sanskrit is the most suitable language for computer software.
5. Ayurveda is the earliest school of medicine known to humans.
6. Although western media portray modern images of India as poverty striken and underdeveloped through political corruption, India was once the richest empire on earth.
7. The art of navigation was born in the river Sindh 5000 years ago. The very word "Navigation" is derived from the Sanskrit word NAVGATIH.
8. The value of pi was first calculated by Budhayana, and he explained the concept of what is now k! nown as the Pythagorean Theorem. British scholars have last year (1999) officially published that Budhayan's works dates to the 6 th Century which is long before the European mathematicians.
9. Algebra, trigonometry and calculus came from India . Quadratic equations were by Sridharacharya in the 11 th Century; the largest numbers the Greeks and the Romans used were 106 whereas Indians used numbers as big as 10 53.
10. According to the Gemmological Institute of America, up until 1896, India was the only source of diamonds to the world.
11. USA based IEEE has proved what has been a century-old suspicion amongst academics that the pioneer of wireless communication was Professor Jagdeesh Bose and not Marconi.
12. The earliest reservoir and dam for irrigation was built in Saurashtra.
13.Chess was invented in India .
14. Sushruta is the father of surgery. 2600 years ago he and health scientists of his time conducted surgeries like cesareans, cataract, fractures and urinary stones. Usage of anaesthesia was well known in ancient India .
15. When many cultures in the world were only nomadic forest dwellers over
5000 years ago, Indians established Harappan culture in Sindhu Valley (Indus Valley Civilisation).
16. The place value system, the decimal system was developed in India in 100 BC Quotes about India .
We owe a lot to the Indians, who taught us how to count, without which no worthwhile scientific discovery could have been 16. The place value system, the decimal system was developed in India in 100 BC Quotes about India .
We owe a lot to the Indians, who taught us how to count, without which no worthwhile scientific discovery could have been made.ALBERT ELINSTEIN. India is the cradle of the human race, the birthplace of human speech, the mother of history, the grandmother of legend and the great grand mother of tradition. Mark Twain If there is one place on the face of earth where all dreams of living men have found a home from the very earliest days when man began the dream of existence, it is India . French scholar Romain Rolland. India conquered and dominated China cultural