Regulatory Affairs Certification (RAC) Practice Exam

Which FDA center is responsible for the regulation of a nasal spray single-entity combination product when a drug serves as its primary mode of action?

1. CDER

2. CVM

3. CBER

4. CFSAN

The correct answer is: CDER

The regulation of a nasal spray single-entity combination product, where the drug serves as its primary mode of action, falls under the purview of the Center for Drug Evaluation and Research (CDER). CDER is the FDA center responsible for ensuring the safety, efficacy, and security of drugs, including prescription medications and over-the-counter products. In this context, since the product is a drug and its primary mode of action is attributed to the drug component, CDER would oversee its approval, labeling, and post-market surveillance. This includes evaluating the pharmacokinetics, pharmacodynamics, and any potential drug interactions associated with the nasal spray formulation. Other centers such as the Center for Veterinary Medicine (CVM) focus on veterinary drugs and animal products, while the Center for Biologics Evaluation and Research (CBER) is mainly concerned with biological products, including vaccines and blood products. The Center for Food Safety and Applied Nutrition (CFSAN) regulates food products and dietary supplements, thus not applicable in this case. Understanding the specific roles of each FDA center is crucial for anyone involved in regulatory affairs.