Book 1B: 2026 FDA Good Clinical Practice Guide <span style="color: #b70202">(With FDA/ICH GCP E6(R3))</span>Description Contents Cover This spiral bound, 5" x 7. 5" book is a compilation of the FDA Good Clinical Practice regulations (21 CFR Parts 11, 50, 54, 56, and 312) and ICH Guidelines (E6, E2A, and E8), as well as the FDA Information Sheets and other guidance documents that govern the conduct of clinical trials for drug research. Please note that this book does NOT contain the sections of 21 CFR Part 314 on New Drug Applications (NDAs). 21 CFR Part 314

Anyone who wants a better understanding of the Good Laboratory Practice Regulations

including updates based on the December 2023 revisions to Part 493 that went into effect on December 28

• Premarketing Risk Assessment

Users requiring ICH guidelines and FDA guidance documents should browse through the other books listed under the heading

September 4

as part of new-employee orientation

for FDA Staff (#7348

5" book is a compilation of various regulatory and guidance documents from the FDA and OHRP on the conduct of research involving children

• 500-749 copies: $21

• 250-499 copies: $22

Chapter 10

54   Financial Disclosure