Accession Number:

ADA496344

Title:

FDA Regulation of Follow-On Biologics

Descriptive Note:

Congressional rept.

Corporate Author:

LIBRARY OF CONGRESS WASHINGTON DC CONGRESSIONAL RESEARCH SERVICE

Personal Author(s):

Report Date:

2009-02-24

Pagination or Media Count:

17.0

Abstract:

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.

Subject Categories:

  • Government and Political Science
  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE