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GMP Publications - Code of Federal Regulation Handbooks by the FDA

GCP - Good Clinical Practice Handbooks

Updated 2024 - 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook
Updated 2024 - 21 CFR 50, 54, 56 - GCP Drug Approval Handbook
Updated 2024 - 21 CFR 312, 314, 511 - Human and Animal Drug Approval
Updated 2024 - 21 CFR 50 - Protection of Human Subjects
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 56 - Institutional Review Boards
Eudralex - Pharmacovigilance for Medical Products Volume 9a
Updated 2024 - 21 CFR 312 - Investigational New Drug Application
21 CFR 314 - Applications for FDA Approval to Market a New Drug
21 CFR 316 - Orphan Drugs
Clinical Master Reference Guide
Electronic Systems Master Handbook 1
21 CFR 320 - Bioavailability and Bioequivalence Requirements
VICH GL9 Animal GCP
Dietary Supplement Master Handbook
ICH Q2(R2) and ICH Q14 Analytical Validation
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
GMP Manufacturing Handbook
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14
Title 21 CFR Parts 1 - End Nine Volume Set
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
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