FDA Law Blog

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d Polin , 194 F.3d

Referral 59

Referral Relationship Government Healthcare 59

FDA Law Blog

JANUARY 12, 2025

FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance. Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.

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Clinic Relationship Provider IT 64

GeriPal

NOVEMBER 2, 2023

Alex: Today we’re delighted to welcome Jerry Gurwitz, who is a geriatrician and professor of medicine at the UMass Chan Medical School. I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Eric: And Alex, who do we have with us today? Jerry, welcome to GeriPal. Jerry: Great to be here.

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Board-Certified IT Community Medical Student 91