Jeff Weinstein

McDermott Will & Emery

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FDA Relaxes on Use of Scientific Info in Off-Label Communications

On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

2/19/2025  /  Food and Drug Administration (FDA) , Health Care Providers , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications

On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

2/18/2025  /  Department of Health and Human Services (HHS) , Enforcement Actions , Final Rules , Food and Drug Administration (FDA) , Health Care Providers , Healthcare Reform , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

FDA Gives Companies a New Way to Fight Misinformation

Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more

7/31/2024  /  Draft Guidance , False Statements , Food and Drug Administration (FDA) , Health Care Providers , Medical Supplies , Pharmaceutical Industry , Prescription Drugs , Public Health , Third-Party
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