Which regulatory body handles New Animal Drug Applications (NADA) and New Drug Applications (NDA)?

• A. APHIS
• B. FDA
• C. EPA
• D. NEPA

Answer: (B)

The key idea is that drug approvals for the market in the United States are handled by the federal agency responsible for drugs, including both human and animal medicines. The FDA approves new drugs through its Drug Evaluation and Research activities, with NADAs overseen by the Center for Veterinary Medicine for animal drugs and NDAs by the Center for Drug Evaluation and Research for human drugs. This centralized authority ensures safety, efficacy, and proper labeling before products can be sold.

Other agencies don’t handle these drug approvals: APHIS is a USDA agency focused on animal health programs rather than drug licensing; EPA regulates pesticides and some related products, but not NADAs/NDAs for conventional medicines; NEPA is a law requiring environmental impact consideration, not a regulatory body that approves drugs.