2025 Manufacturing Provider Specialization 
Minnesota Academy of Family Physicians
MARCH 27, 2025
As we move into the tenth week of the legislative session, Minnesota Academy of Family Physicians (MAFP) lobbyist Megan Verdeja breaks down what’s happening at the Minnesota State Capitol and provides an update on health care bills. 1354 ( Senator Boldon ): On Wednesday, March 19, 2025, the Senate Education Policy Committee heard S.F.
FDA Law
JUNE 25, 2025
FDA issued a companion draft guidance , which provides recommended procedures for companies to meet these requirements. Comments to proposed order OTC0000037 must be submitted by August 4, 2025, and comments to proposed order OTC0000038 and the accompanying draft guidance must be submitted by October 3, 2025. See 16 C.F.R.
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FDA Law Blog
MARCH 9, 2025
The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY. As such, we can offer our readers a special 10% discount. FDA Law Blog is a conference media partner.
FDA Law Blog
FEBRUARY 27, 2025
The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.
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. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Polin , 194 F.3d
FDA Law Blog
DECEMBER 3, 2023
As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.
FDA Law Blog
JUNE 10, 2025
DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. 23,711 (June 4, 2025). 23,483 (June 3, 2025).
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