Which federal agency oversees vaccine development and licensing, including regulatory oversight of biologics?

• A. CDC
• B. FDA (CBER within the FDA) under the Public Health Service Act
• C. NIH
• D. DEA

Answer: (B)

The key idea is that vaccines and other biologics are regulated by the FDA, specifically by the Center for Biologics Evaluation and Research (CBER). This part of the FDA reviews safety and effectiveness, approves products through the Biologics License Application process, and oversees manufacturing quality to ensure vaccines are made and labeled correctly. The legal authority for regulating biologics like vaccines comes from the Public Health Service Act. The CDC, while essential for public health programs, immunization schedules, and post-licensure safety monitoring, does not license vaccines. The NIH focuses on biomedical research, and the DEA handles enforcement related to controlled substances. So, regulatory oversight and licensing of vaccines fall under the FDA’s CBER under the Public Health Service Act.