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FDA reneged on its promise to take a risk-based approach to CDS Software

Mobi Health News

About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.

FDA 49
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Unpacking Averages: Connecting Published Clinical Trials with FDA Drug Approvals

Health Law Advisor

Attorney Bradley Merrill Thompson is the Chairman of the Board and Chief Data Scientist for EBG Advisors and a Member of the Firm at Epstein Becker Green. The opinions expressed in this publication are those of the author.

FDA 52
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Unpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA

Health Law Advisor

Attorney Bradley Merrill Thompson is the Chairman of the Board and Chief Data Scientist for EBG Advisors and a Member of the Firm at Epstein Becker Green. The opinions expressed in this publication are those of the author.

FDA 52
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Unpacking Averages: Violations Found in Medical Device Warning Letters

Health Law Advisor

Attorney Bradley Merrill Thompson is the Chairman of the Board and Chief Data Scientist for EBG Advisors and a Member of the Firm at Epstein Becker Green. The opinions expressed in this publication are those of the author.

FDA 52
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Unpacking Averages: Device Inspection Citations That Frequently Precede Warning Letters

Health Law Advisor

Attorney Bradley Merrill Thompson is the Chairman of the Board and Chief Data Scientist for EBG Advisors and a Member of the Firm at Epstein Becker Green. The opinions expressed in this publication are those of the author.

FDA 52