The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.
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FDA Law Blog
Hyman, Phelps & McNamara, P.C. ... Publication of FDA Law Blog does not create an attorney-client relationship. ... information on FDA Law Blog should be ...www.fdalawblog.net/Eye on FDA
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The Eye on FDA blog reported today that AstraZeneca and Sanofi-Aventis have ... A post at the Pharmalot blog said that the US FDA and the Centers for Disease ...www.biojobblog.com/tags/fda/The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.
Organization
The FDA is an agency within the United States Department of Health and Human Services responsible for protecting and promoting the nation's public health. The FDA is headquartered in Rockville, MD with 223 field offices supported by 13 laboratories located throughout the United States, the U.S. Virgin Islands, and Puerto Rico.
The agency is organized into the following major subdivisions, each focused on a major area of regulatory responsibility:
- The Office of the Commissioner (OC)
- The Center for Drug Evaluation and Research (CDER)
- The Center for Biologics Evaluation and Research (CBER)
- The Center for Food Safety and Applied Nutrition (CFSAN)
- The Center for Devices and Radiological Health (CDRH)
- The Center for Veterinary Medicine (CVM)
- The National Center for Toxicological Research (NCTR)
- The Office of Regulatory Affairs (ORA)
The FDA frequently works in conjunction with other Federal agencies including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection, and Consumer Product Safety Commission. Often local and state government agencies also work in cooperation with the FDA to provide regulatory inspections and enforcement action.
Funding
The FDA's federal budget request for 2008 totaled $2.1 billion, a $105.8 million increase from what it received in 2007.
FDA is also funded by user fees submitted with New Drug Applications under the Prescription Drug User Fee Act (PDUFA)Fact: date=June 2008 in which the industry pays a fee for the review of the new product. A similar process is used for medical devices under the Medical Device User Fee and Modernization Act (MDUFMA)Fact: date=June 2008 and for animal drugs under a similar act. These fees are typically waived or reduced for small businesses.
Legal authority
Most federal laws administered through the FDA are codified into the Food, Drug and Cosmetic Act, also called Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, Controlled Substances Act, and Federal Anti-Tampering Act.
The programs for FDA safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety, yet FDA regulation of cosmetics is focused primarilly on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections.
