The FDA Insider’s Guide to Clinical and Pre-Approval Inspections: A Step-by-Step Guide from IND to NDA
The FDA Knows the Rules. Few Understand the Big Picture.
Most professionals—and even many within the FDA—never get to see how all the pieces truly fit together. Clinical trials (IND), regulatory submissions (NDA/ANDA), and pre-approval inspections (PAIs) are often managed in silos, with little visibility across disciplines.
This is the rare book that connects it all.
The FDA Insider’s Guide to Clinical and Pre-Approval Inspections is written by someone who has stood on both sides of the regulatory table. Former FDA Investigator and global pharmaceutical executive DeVaughn Edwards reveals what few books—and even fewer experts—can explain: how FDA expectations evolve from early-phase clinical research to commercial approval, and how decisions made at the IND stage can unravel your NDA at the finish line.
Whether you're a sponsor, CRO, CDMO, or internal compliance leader, this book delivers the clarity you need to:
- Understand the FDA’s full inspection lifecycle
- Navigate BIMO clinical inspections and manufacturing PAIs as a unified strategy
- Align CMC, quality systems, and clinical operations to avoid fatal disconnects
- Prepare teams with the same tools FDA Investigators use during inspections
- Avoid regulatory delays, 483s, Warning Letters, and rejections
Includes:
✔️ Step-by-step inspection readiness tools
✔️ Practical insight into CPGM 7346.832 (FDA’s internal PAI manual)
✔️ Global best practices from over 15 countries
✔️ Templates, checklists, and proven compliance strategies
If you're preparing for FDA engagement—or recovering from it—this book is your advantage.
Even FDA Investigators should read it.
The FDA Insider’s Guide to Clinical and Pre-Approval Inspections By DeVaughn Edwards, Former FDA Investigator & Global Compliance Consultant Are you preparing for a clinical inspection or a Pre-Approval Inspection (PAI)? Don’t guess. Learn from someone who’s been on both sides of the door. This expert-level guide bridges the gap between clinical development (IND) and commercial readiness (NDA/ANDA), providing rare, real-world insight into how FDA inspections actually work — and how to prepare for them. What You’ll Get: ✅ Step-by-step breakdown of the FDA regulatory process ✅ Clinical (BIMO) and PAI inspection frameworks demystified ✅ Detailed guidance on IND, NDA, ANDA, and CMC requirements ✅ Insights into FDA’s internal inspection manual (CPGM 7346.832) ✅ Inspection readiness checklists, tools, and strategies used globally ✅ Remediation guidance, document index templates, and best practices ✅ Real-world examples from 15+ countries and over 30 years of experience Whether you're a QA lead, Regulatory Affairs professional, CRO, CDMO, or CEO preparing for regulatory scrutiny, this book will make the difference between inspection success and costly delays. Why it matters: Most professionals (and even many inside the FDA) don’t understand how clinical inspections and pre-approval manufacturing inspections connect. This book explains it — clearly, completely, and powerfully. This is the guide even FDA should read.