Which center is responsible for evaluating biologics?

The Center for Biologics Evaluation and Research (CBER) is the correct answer as it is specifically responsible for evaluating biologics, which include a wide range of products such as vaccines, blood products, and cellular and gene therapies. CBER ensures that these biologics are safe, effective, and manufactured in compliance with regulatory standards before they can be marketed and distributed in the United States. This center plays a critical role in overseeing the development and licensure of biologics and addresses their unique regulatory needs.

In contrast, the Center for Drug Evaluation and Research (CDER) focuses primarily on pharmaceutical drugs, while the Center for Devices and Radiological Health (CDRH) is dedicated to regulating medical devices. The FDA, as the overarching agency, encompasses all these centers but does not evaluate biologics directly; rather, it oversees the work carried out by CBER.