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Publications

Recent Publications

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

“The 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

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