Food and Drug Administration

Definition

The Food and Drug Administration (FDA) is a U.S. federal agency responsible for regulating food, drugs, medical devices, and biological products. It ensures the safety, efficacy, and security of these products to protect public health.

5 Must Know Facts For Your Next Test

1. The FDA oversees clinical trials for gene therapy to ensure they are safe and effective.
2. Gene therapies must receive FDA approval before being marketed or used in treatments.
3. The FDA's Center for Biologics Evaluation and Research (CBER) is primarily responsible for regulating gene therapy products.
4. The FDA provides guidelines for both preclinical studies and clinical trials involving microbial vectors in gene therapy.
5. Post-market surveillance by the FDA ensures ongoing safety monitoring of approved gene therapies.

Review Questions

• What role does the FDA play in the regulation of gene therapy?
• Which division of the FDA is responsible for overseeing gene therapy products?
• Why is post-market surveillance important for gene therapies according to the FDA?

Related terms

Clinical Trial: A research study that tests how well new medical approaches work in people.

Biologics License Application (BLA): A request for permission to introduce a biologic product into interstate commerce.

CBER (Center for Biologics Evaluation and Research): The branch of the FDA that regulates biological products including vaccines, blood products, and gene therapies.