Physician's Practice
JUNE 9, 2025
of Roetzel & Andress June 9, 2025 By Austin Littrell Fact checked by Keith A. Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. Austin Littrell June 2nd 2025 Podcast Tom Price, M.D.,
FDA Law Blog
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.,
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FDA Law Blog
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.
FDA Law Blog
NOVEMBER 8, 2022
If you have a good relationship with the review team, Dr. Maisel encourages a brief phone call or quick email to obtain informal feedback. In closing, he advised manufacturers who plan to market their products beyond the public health emergency to plan to submit marketing applications. Advance health equity.
FDA Law Blog
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.
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