FDA Regulatory Affairs: Operational Guidance for Clinical Development (Clinical Research & Regulatory Affairs) by David Lew
English | February 9, 2026 | ASIN: B0GL9GNGDW | 548 pages | EPUB | 1.18 Mb
Updated for 2026 to reflect current FDA regulations and clinical development practice.
FDA regulatory work requires a team to determine which source controls a decision and how the requirement applies to a specific product. The team also has to document the rationale before work moves forward. Statutes, 21 CFR, FDA guidance, center practice, product type, and lifecycle stage all matter. Problems usually start when teams rely on memory or informal interpretation, or when they document the rationale too late to guide the work.
FDA Regulatory Affairs: Operational Guidance for Clinical Development connects FDA expectations to clinical development work across the product lifecycle. It explains how teams use statutes and 21 CFR requirements to build plans and controls, with FDA guidance supporting documentation that can hold up under review.
The book follows the product lifecycle from premarket through postmarket, distinguishing medical-device pathways from those used for drugs and biologics. Topics include product classification and jurisdiction, regulatory pathways, FDA meeting strategy, quality systems, data integrity, clinical trial compliance, inspections and 483 response, safety reporting, pharmacovigilance, labeling and promotion, recalls and corrections, postmarket oversight, and regulatory intelligence.
Teams document regulatory decisions in protocols, submissions, plans, procedures, and quality records. That record supports lifecycle control, including inspection preparation and safety processes.
This book is written for professionals and leaders working in clinical operations, regulatory affairs, quality, and project management. It is also for graduate students in those fields.
Readers can use the book to:
- Apply FDA primary sources to practical deliverables and clear ownership
- Plan pathway strategy across IND, IDE, NDA, BLA, 510(k), De Novo, PMA, and lifecycle changes
- Prepare FDA meetings and communications with a clear record that links each question to its rationale and final decision
- Build inspection-ready clinical and quality operations, including safety work, with defined escalation paths supported by disciplined documentation.
- Support safety reporting and postmarket oversight by defining the reportability logic and timeline, then documenting each handoff
- Sustain compliance through change control and remediation. Document the governance for recalls or corrections.
Read the book end to end for structure. During planning and execution, use it as a working reference that also supports inspection preparation.
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