Entries from HEALTH LAW SECTION BLOG tagged with 'nonclinical safety/efficacy studies'

Human Clinical Trials,Marketing Authorization for Pharmaceuticals-ICH

From FDA/CBER, Sept 4, 2008, a follow up on an ICH Harmonised Tripartite Guideline document, 'Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals' (M3(R2) Current Step 2 version dated 15 July...

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