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) : Johnson, Judith A
Report Date : 24 Feb 2009
Pagination or Media Count : 17
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.
Descriptors : *CLINICAL MEDICINE , *REGULATIONS , VACCINES , LEGISLATION , CHEMICAL REACTIONS , CONGRESS , DRUGS
Subject Categories : Government and Political Science
Medicine and Medical Research
Distribution Statement : APPROVED FOR PUBLIC RELEASE