FDA Law

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

SEPTEMBER 6, 2022

Below we outline the Draft Guidance and highlight the new information in the 2022 Draft Guidance. Two of the new questions added in the Draft Guidance (Q22 and Q23) address the fact that monitoring and other administrative “startup” costs, and manufacturing costs are often higher in the first year compared to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.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law

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.

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Chronic Disease Government Clinic Chronic Condition 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. Its major goal is to try to pull together information on aging and climate change for three groups. Karl: Sure.

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Healthcare IT Education Community 129

FDA Law

MAY 26, 2025

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. Driehaus , 573 U.S. 149, 158 (2014). See 21 U.S.C.

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Manufacturing Provider Medical IT 59