FDA Regulation of Follow-On Biologics.

Discusses proposal to create FDA pathway for approval of follow-on biologics, which are medical preparations made from living organisms. Provides introduction to relevant law, FDA regulatory framework, and scientific challenges for FDA in considering approval of follow-on biologics; and describes pr...

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Bibliographic Details
Corporate Authors:	Library of Congress. Congressional Research Service, ProQuest (Firm)
Format:	eBook
Language:	English
Published:	[Place of publication not identified] : [publisher not identified], 2008.
Series:	U.S. Congressional Research.
Subjects:	Medical laws and legislation. Electronic books.
Online Access:	Connect to the full text of this electronic book

Description
Summary:	Discusses proposal to create FDA pathway for approval of follow-on biologics, which are medical preparations made from living organisms. Provides introduction to relevant law, FDA regulatory framework, and scientific challenges for FDA in considering approval of follow-on biologics; and describes proposed legislation.
Item Description:	Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Dec. 2010). Reuse except for individual research requires license from ProQuest, LLC. CRS Report. Electronic resource.
Physical Description:	1 online resource.