Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach (Hardcover)

PART 1: Overview

Introduction: Overview of the FDA, [Dr. Gurman, Dr. Rosen, Dr. Elman]

Understanding Clinical Trials for Drugs and Devices with Case studies [Dr. Gurman]

Designing Clinical Trials for FDA [Clinical Trials Consulting Group TBD]

Simplifying the process of FDA submission and clearance

Interacting with the FDA [FDA consulting group, TBD]

Recalls and Failures

Patient Safety and Satisfaction [Dr. Ronen Rozenblum et al, Unit of Patient Satisfaction, Safety, Brigham Women’s Hospital, Harvard Medical School)

FDA and other regulatory requirements [Dr. Willie Foerstener et al, Medical Device Consultant]

Capital Challenges

Technology Transition [Dolphin Consulting Group, Dr. Steve Jarret]

Business Transformations for FDA Clearance

Appendix and FDA Reference (Dr. Gurman)