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What drugs are regulated by the HHS Food Drug and Administration (FDA)?


From aspirin to cancer treatments, FDA’s Center for Drug Evaluation and Research (CDER) ensures that the benefits of drug products outweigh any known risks. The Center has oversight responsibilities for prescription, over-the-counter and generic drugs. This responsibility includes products that many consumers usually do not associate as drugs, such as fluoride toothpaste, dandruff shampoos and sunscreens. CDER carefully evaluates the benefits and risks of drugs and ensures that consumers have access, as quickly as possible, to promising new treatments. The Center oversees the research, development, manufacture and marketing of drugs. CDER ensures truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks. If unexpected risks are detected after approval, CDER takes action to inform the public, change a drug's label, or--if necessary--remove a product from the market. Specifically, CDER regulates:

  • Prescription Drugs: Prescription medicines include any drug product that requires a doctor's authorization to purchase.
  • Generic Drugs: A generic drug is a drug product that is equivalent to brand name products in terms of quality and performance.
  • Over-the-Counter Drugs: OTC drug products are available to consumers without a doctor's prescription.

Learn More:

  • Drug Information Pathfinder. Provides links to information on specific drugs, drug development, drug application process, drug imports, and other topics. 


Last Updated: 04/22/2008