Regulatory Affairs Certification (RAC) 2025 – 400 Free Practice Questions to Pass the Exam

The correct answer is CBER, which stands for the Center for Biologics Evaluation and Research. This FDA center is specifically tasked with the regulation of biologics, which includes a wide array of products such as vaccines, blood and blood products, cellular therapies, gene therapies, and tissues. CBER's primary mission is to ensure the safety, purity, potency, and effectiveness of these biologics, which are critical for public health.

CBER plays a vital role in the premarket evaluation of biologics, assessing data from clinical trials to ensure that these products meet the required standards before they can be distributed to the public. Furthermore, CBER continues to monitor the safety of biologics after they are approved, contributing to ongoing safety surveillance.

Understanding the distinction between the various FDA centers is essential for regulatory affairs professionals. For example, CDER (Center for Drug Evaluation and Research) focuses on the approval of small molecule drugs, while CVM (Center for Veterinary Medicine) regulates veterinary products. CFSAN (Center for Food Safety and Applied Nutrition) oversees food products, dietary supplements, and cosmetics. Each center has its unique scope of responsibility, and recognizing these differences is key to navigating the regulatory landscape effectively.