Fda Drug Review Process

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The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident For example, Retrovir (zidovudine, also known as AZT) was first studied as an anti-cancer drug in the 1960s with disappointing results. It wasn't until the 1980s that researchers discovered the drug could treat AIDS, and the Food and Drug Administration approved the drug, manufactured by GlaxoSmithKline, for that purpose in 1987. Most drugs that undergo preclinical (animal) testing never even make it to human testing and review by the FDA. The…show more content…
The FDA uses postmarket requirement and commitment studies to gather additional information about a product's safety, efficacy, or optimal use. New Drug Application (NDA)--This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured. When an NDA comes in, the FDA has 60 days to decide whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete. For example, some required studies may be missing. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA's Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later than 10 months after the applications are received. The review goal is six months for priority drugs. (See "The Role of User…show more content…
CDER conducts about 300-400 clinical investigator inspections annually. About 3 percent are classified in this "official action indicated" category. The FDA has established an independent Drug Safety Oversight Board (DSOB) to oversee the management of drug safety issues.. The Board meets monthly and has representatives from three FDA Centers and five other federal government agencies. The board's responsibilities include conducting timely and comprehensive evaluations of emerging drug safety issues, and ensuring that experts--both inside and outside of the FDA--give their perspectives to the agency. The first meeting of the DSOB was held in June 2005. Surce: http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm ow is a medicine approved by

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