FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. The case law on commission-based marketing agentsincluding the Sorensen decisionfollow in a similar vein.

Referral 59

Referral Relationship Government Healthcare 59

FDA Law Blog

SEPTEMBER 6, 2022

Two of the new questions added in the Draft Guidance (Q22 and Q23) address the fact that monitoring and other administrative “startup” costs, and manufacturing costs are often higher in the first year compared to subsequent years. These new Q & As explain that some sponsors may amortize costs.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law Blog

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

GeriPal

DECEMBER 7, 2023

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. But Ruth, I was wondering too, and you invited us to ask each other questions, so my golly I’m going to do it.

Healthcare 129

Healthcare IT Education Hospital 129

FDA Law Blog

MAY 26, 2025

Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. Second, absent some kind of contractual relationship between a provider and a manufacturer, a provider is generally immune from misbranding if the provider is not also selling a regulated product. Driehaus , 573 U.S.

Manufacturing 59

Manufacturing Provider Medical General Practice 59