Information gathered from press releases and other public notices about recalls of FDA-regulated products.
All prescription drugs that desire to be marketed in the U.S. must gain the approval of the Food and Drug Administration (FDA). Through the Center for Drug Evaluation and Research (CDER), which assures that safe and effective drugs are available to the American people, a prescription drug must pass a series of trials. Please understand that the FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of a drug's studies to the CDER so that the Center can evaluate its data. The studies answer the question, "Does this drug work for the proposed use?" By analyzing the data, CDER reviewers assess the benefit-to-risk relationship and determine if the drug will be approved. Once the drug has been placed on the market, the FDA continues to monitor it through post-marketing reports sent in by the manufacturer and through the MedWatch program - an FDA program that allows consumers and health care professionals to report serious side effects, quality control issues, and medical errors associated with drugs and products regulated by the FDA.
Sometimes, an unanticipated side effect manifests itself once the drug has been made available to the U.S. market. If the side effect is serious enough, the FDA may issue a warning to the public and request that changes be made to the drug's label. If the side effect is extremely serious and the FDA decides that the risks of the drug outweigh its benefits, then the FDA may recall the drug.
This section includes drug marketing and advertising warning letters from the FDA to pharmaceutical companies.
MedWatch issues alerts from the FDA Safety Information and Adverse Event Reporting Program.
Food and Drug Administration
The FDA mission is to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws which are designed to protect consumers' health, safety, and pocketbook. Pharmaceutical drugs and medical devices must be safe and effective, radiation-emitting devices must meet established standards, and all products must contain informative and truthful labeling in English.
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