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· 분류 : 외국도서 > 의학 > 생명공학
· ISBN : 9781482207088
· 쪽수 : 400쪽
목차
PART 1: Overview
Introduction: Overview of the FDA, [Dr. Gurman, Dr. Rosen, Dr. Elman]
PART 2: Clinical Considerations
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)
PART 3: Technological Considerations
FDA and other regulatory requirements [Dr. Willie Foerstener et al, Medical Device Consultant]
PART 4: Industry and Business Considerations
Capital Challenges
Technology Transition [Dolphin Consulting Group, Dr. Steve Jarret]
Business Transformations for FDA Clearance
PART 5: Appendix and FDA Reference for Cleared Biomedical and Biomaterials
Appendix and FDA Reference (Dr. Gurman)