Book 14: 2026 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

• Nonclinical evaluation of potential for delayed QT

211   Current Good Manufacturing Practice for Finished Pharmaceuticals

Payments to Study Subjects

• NDA Review Process

Emergency Use of Investigational Products

IRBs and HIPAA Privacy

• Clinical research monitors (CRAs)

• New Drug Development Process

The textual content of this book is identical to the official ORI book

Part IV: Reporting and Reviewing Research

This book is ideal for clinical research staff involved in developing and reviewing protocols

164  Privacy of Individually Identifiable Health Information