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...
| Corporate Authors: | Library of Congress. Congressional Research Service, ProQuest (Firm) |
|---|---|
| Format: | eBook |
| Language: | English |
| Published: |
[Place of publication not identified] :
[publisher not identified],
2009.
|
| Series: | U.S. Congressional Research.
|
| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
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