Franklin

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

Author/Creator:
Library of Congress. Congressional Research Service.
Publication:
[S.l] : [s.n.], 2009.
Format/Description:
Government document
Book
1 online resource (16 p., digital, PDF file)
Status/Location:
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Subjects:
Medical laws and legislation.
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 110th and 111th Congresses.
Notes:
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.
Other format:
Microfiche version: Library of Congress. Congressional Research Service. FDA Regulation of Follow-On Biologics
Access Restriction:
Restricted for use by site license.