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Emerging Health
Consulting Areas
Consulting Areas
Experts
Experts
Media
Publications & Presentations
Guides
Industry Terms
Client Portal
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James A. Feldman, MD

Emergency Medicine

Kirk Moore

, PhD

Economics

Jonathan S. Olshaker, MD

Emergency Medicine

Omar Robles

, PhD,MBA

Economics

Brenda Rodriguez

, MS,MBA

Global Health

Commercial Litigation

Health Communications

Management Consulting

Health Education

Program Evaluation

Strategic Planning

Publications

Recent Publications

Harmonizing Safety and Speed: A Human-Algorithm Approach to Enhance the FDA's Medical Device Clearance Policy, SSRN, June 2024.

β€œThe Accelerated Approval Program: Desiderata for a Proper Solution to the Untimely Completion of Confirmatory Trials,” Update Magazine, Food and Drug Law Institute, Winter 2023.

"Create An Economic Incentive For The Timely Completion Of Confirmatory Trials", Health Affairs Forefront, August 1, 2023. doi: 10.1377/forefront.20230727.205048

β€œRegulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance.” JAMA. 2023;329(18):1609. doi:10.1001/jama.2023.4089

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