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GMP Publications - Code of Federal Regulation Handbooks by the FDA

Updated 2024 - 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook
Clinical Master Reference Guide
Medical Device Clinical with EU Directive
ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Updated 2024 - 21 CFR 50, 54, 56 - GCP Drug Approval Handbook
21 CFR 11 - with Scope & Application & Computerized Systems used in Clinical Investigations
21 CFR 54 - Financial Disclosure by Clinical Investigators
ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ICH E8 - General Considerations for Clinical Studies
ICH E6(R2) - Good Clinical Practice
21 CFR 320 - Bioavailability and Bioequivalence Requirements
ICH Q2(R2) and ICH Q14 Analytical Validation
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14
In Vitro Diagnostics Master Handbook
VICH GL9 Animal GCP
Title 21 CFR Parts 1 - End Nine Volume Set
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
Mix and Match Interphex 2024 Sterile GMP End of Year Special New Books GMP GCP-DRUG Featured Publication Featured Publication
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