Research Ethics

How does the U.S. Food and Drug Administration (FDA) regulate drugs?
Answered by Discovery Channel
  • Discovery Channel

    Discovery Channel

  1. The FDA requires that producers of prescription and over-the-counter drugs must demonstrate a drug's safety before it is allowed to be placed on the market. Drugs are tested by their producer for an average of 8.5 years in both labs and clinical trials. Following these tests, the producers must file an appeal to the FDA for the drug's approval. If the FDA approves the drug, it's classified as a prescription or over-the-counter drug. If not, the drug can't be sold in the United States. Approximately 0.1 percent of drugs tested in labs gain FDA approval.

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