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


Full Text : https://apps.dtic.mil/dtic/tr/fulltext/u2/a496344.pdf


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