Book 14: 2025 Selected Recently-Finalized FDA Guidance DocumentsDescription Contents Cover Rapidly becoming one of our most popular titles, this spiral bound, 5" x 7. 5" book is a collection of FDA Guidance documents. It includes those guidances that are most applicable to clinical research staff and includes such topics as: Maximum safe starting dose estimates Safety assessments prior to drug marketing Collecting race ethnicity data in trials Nonclinical evaluation of potential for delayed QT interval

December 22

When will Rave ALS 7

• Draft FDA Guidance: Electronic Source Data in Clinical Investigations

Recruiting Study Subjects

Parts  11    Electronic Records/Electronic Signatures

Federal Register

5" book is a compilation of regulations and guidance documents on the Administrative Simplification Provisions of the Health Insurance Portability and Accountability Act (HIPAA)

February 2

November 9

21CFR parts 11

5" book is a compilation of FDA regulations and guidance documents on biologics

• OHRP Human Subjects Regulations Decision Charts