Food and Drug Administration (FDA)

Definition

The Food and Drug Administration (FDA) is a U.S. government agency responsible for regulating food, pharmaceuticals, medical devices, and other health-related products. It ensures the safety, efficacy, and security of drugs and medical products available to the public.

5 Must Know Facts For Your Next Test

1. The FDA approves new drugs before they can be marketed in the United States.
2. It regulates both prescription and over-the-counter medications.
3. The FDA requires clinical trials to ensure drug safety and effectiveness before approval.
4. It also monitors adverse drug reactions through post-marketing surveillance programs.
5. The FDA enforces labeling requirements to provide essential information about drug use and risks.

Review Questions

• What role does the FDA play in the approval of new drugs?
• How does the FDA ensure the ongoing safety of approved medications?
• What are some key areas regulated by the FDA besides pharmaceuticals?

Related terms

Clinical Trials:

Research studies performed on humans to evaluate medical, surgical, or behavioral interventions.

Prescription Drugs: Medications that legally require a medical prescription to be dispensed.

Adverse Drug Reactions:

Unwanted or harmful reactions experienced following the administration of a drug or combination of drugs under normal conditions of use.