Food and Drug Administration

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Food and Drug Administration

(FDA), agency of the Public Health Service division of the U.S. Department of Health and Human Services. It is charged with protecting public health by ensuring that foods are safe and pure, cosmetics and other chemical substances harmless, and products safe, effective, and honestly labeled. The Food, Drug, and Cosmetic Act of 1938 and various bills since have strengthened government control by requiring prior-evidence-of-safety tests and procedures for new drugs, pesticides, and additives and colorings in foods and cosmetics. The FDA was first established in 1931; in 1940 it was transferred from the Dept. of Agriculture to the Federal Security Agency and in 1953 to the Dept. of Health, Education and Welfare, which was redesignated as Health and Human Services in 1979. The FDA consists of the centers for Drug Evaluation and Research, Biologics Evaluation and Research, Food Safety and Applied Nutrition, Veterinary Medicine, Devices and Radiological Health, and Toxicological Research. In the early 1990s, in response to criticism that its time-consuming approval processes penalized people with AIDS, it extended the classification system it uses to prioritize drugs in order to give AIDS drugs the highest priority; it also subsequently sped up the approval process for cancer drugs. Congressional legislation in 1997 mandated an overhaul of the FDA in order to speed review of new drugs and medical devices.


See P. J. Hilt, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003) and D. Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (2010).

References in periodicals archive ?
Other articles address acceptance of state law to establish a municipal charges lien for treasurer/collector fees and charges; authorizing selectmen to negotiate a payment-in-lieu-of-taxes agreement for a 1-megawatt solar power installation at 15 Buxton Road; authorizing the Board of Selectmen to acquire an easement for access to the Gifford Cemetery; authorizing conveyance to the town of the Southwick Cemetery and Aldrich Cemetery; a citizen's petition to rezone 775 Millville Road to industrial from residential C; and a citizen's petition to rezone 124/126 North Main St.
Reckitt Benckiser (RB) notes that the US Food and Drug Administration (FDA) has denied a Citizen's Petition filed by the RB Pharmaceuticals business (RBP).
Genentech's Citizen's Petition to the FDA is an important step in the movement towards in vitro diagnostic regulatory standardization.
In March, the public advocacy group Public Citizen filed a citizen's petition with the FDA, stating that the drug had been associated with 29 deaths and "hundreds of serious adverse reactions" since its introduction in 1998.
The Cosmetic, Toiletry & Fragrance Association (CTFA) and the Soap and Detergent Association (SDA) task force recently filed a citizen's petition with the Food and Drug Administration (FDA) for amendments to the OTC labeling requirements enacted on June 17, 1994 on a tentative final monograph (TFM) for health care antiseptic products.
Biovail and its licensee, Teva Pharmaceuticals, collaborated in filing a Citizen's Petition and a lawsuit with the FDA requesting that final approval of Biovail's product be effected immediately.
Their petition stated, "None of the signers of this citizen's petition are opposed to progress, if it's the result of thoroughly informed planning.
WASHINGTON -- AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS nonprofit medical provider, today announced that has filed what is known as a citizen's petition with the Food and Drug Administration (FDA) asking the FDA to 'delay or deny' approval of an application by Gilead Sciences for expedited review of its blockbuster AIDS drug Truvada for expanded use as a method of preventing HIV infection in non-infected people.
But even while rejecting the citizen's petition as essentially unconstitutional, Mr.
The Campaign to Fix the Debt, a non-partisan grassroots coalition of business leaders and CEOs, former Members of Congress, and everyday concerned citizens, launched the Citizen's Petition in August.
The Food and Drug Administration is still considering a citizen's petition signed by more than 70 medical associations asking that, emergency contraception be made available over the counter (OTC), the Center for Reproductive Law and Policy says.