GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R1) - 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
21 CFR 50, 54, 56 - GCP Drug Approval Handbook
21 CFR 11 - Electronic Records 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 Trials
ICH E6(R1) - Good Clinical Practice
21 CFR 320 - Bioavailability and Bioequivalence Requirements
In Vitro Diagnostics Master Handbook
Audit - US
VICH GL9 Animal GCP
Title 21 CFR Parts 1 - End Nine Volume Set
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
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