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This Guidance has been Finalized
Guidance for Industry:
INDs — Approaches to Complying with CGMP During Phase 1
Draft Guidance http://www.fda.gov/cder/guidance/6164dft.pdf has been replaced.
The Final Version: entitled: Guidance for Industry:
CGMP for Phase 1 Investigational Drugs can be accessed at: http://www.fda.gov/cber/gdlns/indcgmp.pdf
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Date created: November 3, 2008 |
