FDA Regulation of Follow-On Biologics [electronic resource].
- [S.l] : [s.n.], 2009.
- Government document
1 online resource (16 p., digital, PDF file)
- Medical laws and legislation.
- 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.
- 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.
- Other format:
- Microfiche version: Library of Congress. Congressional Research Service. FDA Regulation of Follow-On Biologics
- Access Restriction:
- Restricted for use by site license.
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