FDA Law

MAY 7, 2025

On April 14, 2025, the Seventh Circuit overturned the criminal conviction of Mark Sorensen, the owner of a durable medical equipment (DME) distributor, who had been found guilty of violating the AKS. In evaluating non-safe harbored, commission-based marketing agents (e.g.,

Referral 59

Referral Relationship Government Healthcare 59

FDA Law

SEPTEMBER 20, 2021

Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors. 31, 2022; CDRP start, FY 2023; Public workshop, by July 31, 2025; Strategy document published, by April 30, 2026.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

MAY 26, 2025

The political battle went into gear on January 28, 2025, with an Executive Order titled Protecting Children from Chemical and Surgical Mutilation. The EO and DOJ memo were followed by a May 1, 2025 announcement of a report from the U.S. The gray box at the top of the document at this link shows the change in position. See 21 U.S.C.

Manufacturing 59

Manufacturing Provider Medical IT 59