FDA Regulation of Follow-On Biologics [electronic resource].

Corporate Author:: Library of Congress. Congressional Research Service
Published:: [Place of publication not identified] : [publisher not identified], 2009.
Physical Description:: 20 pages : digital, PDF file

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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 in the 111th Congress.

Subject(s):

Medical laws and legislation

Related Titles:

ProQuest U.S. Congressional Research Digital Collection

Note:

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.
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