Center for Drug Evaluation and Research (CDER)

Definition

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

5 Must Know Facts For Your Next Test

1. CDER is crucial in the regulation of gene therapy products to ensure their safety and efficacy.
2. It oversees clinical trials for new drug applications, including those involving microbial genetics.
3. CDER works closely with other regulatory bodies to develop guidelines specific to gene therapy approaches.
4. The center has specific protocols for evaluating genetically engineered microorganisms used in drug development.
5. CDER's approval process includes a rigorous review of both preclinical and clinical data.

Review Questions

• What role does CDER play in the evaluation of gene therapy products?
• How does CDER ensure the safety and efficacy of new drugs involving microbial genetics?
• What are some key elements that CDER reviews during the approval process of genetically engineered microorganisms?

Related terms

FDA: U.S. Food and Drug Administration, responsible for protecting public health by ensuring food, drugs, and cosmetics are safe.

Clinical Trials: Research studies conducted with human participants to evaluate medical, surgical, or behavioral interventions.

Gene Therapy: A technique that modifies a person's genes to treat or cure disease.