Center for Drug Evaluation and Research (CDER)

Definition

The Center for Drug Evaluation and Research (CDER) is a branch of the U.S. Food and Drug Administration (FDA) responsible for ensuring that drugs marketed in the United States are safe and effective. CDER evaluates new drugs before they can be sold and monitors existing drugs to ensure continued safety.

5 Must Know Facts For Your Next Test

1. CDER is part of the FDA, a federal agency in the United States.
2. It reviews applications for new pharmaceuticals, including both prescription and over-the-counter medications.
3. CDER monitors post-market drug safety through adverse event reporting systems.
4. It ensures that drug labeling provides accurate information about uses, risks, and benefits.
5. The center also oversees generic drug approvals to ensure they meet the same standards as brand-name drugs.

Review Questions

• What federal agency does CDER belong to?
• What types of drugs does CDER evaluate before they can be sold in the U.S.?
• How does CDER contribute to post-market drug safety?

Related terms

FDA: The U.S. Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs.

New Drug Application (NDA): A comprehensive document submitted to the FDA that includes all data on a drug's efficacy, safety, pharmacokinetics, and proposed labeling.

Generic Drugs: Medications with the same active ingredients as brand-name drugs but generally sold at lower prices after patent protections expire.