FDA Regulation of Follow-On Biologics
Description:
This report provides a brief introduction to the relevant law regarding follow-on biologics, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a description of the proposed legislation.
Date:
February 24, 2009
Creator:
Johnson, Judith A.
Item Type:
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Partner:
UNT Libraries Government Documents Department