FDA Regulation of Follow-On Biologics
LIBRARY OF CONGRESS WASHINGTON DC CONGRESSIONAL RESEARCH SERVICE
Pagination or Media Count:
Congress has been considering legislation that would expand regulatory activities of the Food and Drug Administration FDA by opening a pathway for the approval of follow-on biologics. A biologic is a preparation, such as a drug or a vaccine, that is made from living organisms. A follow-on biologic is similar to the brand-name innovator product made by the pharmaceutical or biotechnology industry. In contrast to a biologic, most commonly used drugs are synthesized via a chemical process.
- Government and Political Science
- Medicine and Medical Research