GMP Publications - Code of Federal Regulation Handbooks by the FDA

Clinical

21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R1) - Good Clinical Practice Handbook - Includes the June 24th, 2011 Changes
21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination - Includes the June 24th, 2011 Changes
21 CFR 312, 314, 511 - Human and Animal Drug Approval
21 CFR 50, 54, 56 - GCP Drug Approval Handbook -Includes the June 24th, 2011 Changes
Clinical Master Reference Guide
Eudralex - Pharmacovigilance for Medical Products Volume 9a
Medical Device Clinical with EU Directive
US, EU and Canadian Medical Device Combination
Audit Fee US
example: 211, (ISBN), ...xxx-60-9,, Drug, GMP, Etc.
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