What is required for a drug to be approved by the HHS Food Drug and Administration (FDA)?

Answer

Under current law, all new drugs need proof that they meet standards of quality and are effective and safe for their intended use before they can be approved for marketing. No drug is absolutely safe; there is always some risk of an adverse reaction. FDA decides—after a thorough evaluation—whether the studies submitted by the drug's sponsor (usually the manufacturer) show it to be safe and effective for its intended use. When a proposed drug's benefits outweigh known risks, FDA considers it safe enough to approve. Once a drug gets FDA approval, the drug is on the market as soon as the firm gets its production and distribution systems going.

Learn More:

• FDA's Drug Safety Initiative
• From Test Tube to Patient, Protecting America's Health Through Human Drugs (FDA)

Last Updated: 04/22/2008