An ANDA is submitted to which FDA center?

• A. CDER
• B. CBER
• C. CFSAN
• D. ORA

Answer: (A)

An ANDA goes to the FDA center that handles drugs, specifically generics. An Abbreviated New Drug Application is the pathway to obtain approval for a generic version of a previously approved drug, with emphasis on demonstrating bioequivalence and consistent manufacturing, rather than repeating full safety/efficacy studies. The Center for Drug Evaluation and Research reviews these generic-drug applications and ensures they are safe, effective, and interchangeable with the reference product. Other FDA centers handle different product areas—biologics belong to the Center for Biologics Evaluation and Research, foods and some cosmetics to the Center for Food Safety and Applied Nutrition, and the Office of Regulatory Affairs oversees inspections and enforcement rather than reviewing drug applications. Therefore, an ANDA is submitted to the Center for Drug Evaluation and Research (CDER).