Which regulatory path governs manufacturing and labeling of biologic drugs overseen by FDA’s CBER?

• A. Biologics regulation under the Public Health Service Act
• B. Food, Drug, and Cosmetic Act
• C. Controlled Substances Act
• D. Medical Device Regulation

Answer: (A)

Biologics overseen by FDA’s CBER are regulated under the Public Health Service Act. This Act provides the authority for licensing biologic products, with manufacturing, labeling, and safety requirements carried out through the Biologics License Application process. While the Food, Drug, and Cosmetic Act governs many traditional drugs, devices, and cosmetics, biologics are part of a separate regulatory framework managed by CBER under the PHS Act. The other statutes listed don’t authorize the licensing path for biologics (for example, the Controlled Substances Act is about controlled substances, and Medical Device Regulation covers devices, not biologics).