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Draft Guidance http://www.fda.gov/cder/guidance/6164dft.pdf has been replaced.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
Back
to Top
Back to Guidance Page
PDF requires the free Adobe
Acrobat Reader
Date created: November 3, 2008 |