FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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FDA Law Blog

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). At the center of Pfizer’s argument is whether an AKS violation requires corrupt intent. Background. Borrasi, 639 F.3d 3d 774 (7th Cir.

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FDA Law Blog

MAY 7, 2025

Seventh Circuit ruling in Sorensen In Sorensen , the government alleged, and the District Court agreed, that Sorensen paid illegal kickbacks to marketing firms based on the number of leads generated and a DME manufacturer based on the percentage of funds collected from Medicare. In contrast to its decision in United States v. Polin , 194 F.3d

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Annals of Family Medicine

NOVEMBER 20, 2024

2) Those unable to provide abortion care will: a) learn about evidence-based use of mifepristone for abortion care; b) implement supportive referrals for patients seeking abortion care. Objectives: 1) Participating clinics begin to provide mifepristone for early pregnancy loss (EPL) and/or abortion care.

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FDA Law Blog

MARCH 31, 2025

The Department of Justice (DOJ) has an existing referral process whereby the FTC must first consult with the USAG before filing a case in federal court for civil penalties. But despite EO 14215 and the existing referral process, S. The latest iteration of proposed Section 27 in S.

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Consulting Manufacturing Referral IT 64

FDA Law Blog

APRIL 2, 2025

The Department of Justice (DOJ) has an existing referral process whereby the FTC must first consult with the USAG before filing a case in federal court for civil penalties. But despite EO 14215 and the existing referral process, S. The latest iteration of proposed Section 27 in S.

Consulting 59

Consulting Manufacturing Referral IT 59