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

Author
Library of Congress. Congressional Research Service [Browse]
Format
Book
Language
English
Published/​Created
[S.l] : [s.n.], 2008.
Description
19 p. : digital, PDF file.

Details

Subject(s)
Summary note
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.
Notes
  • CRS Report.
  • 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.
System details
System requirements: PDF reader software.
Other title(s)
ProQuest U.S. Congressional Research Digital Collection.
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