Jeff Weinstein

McDermott Will & Emery

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New SEC Leadership Signals Continued Focus on FDA-Related Disclosures

Lawyers inside and outside the US Securities and Exchange Commission (SEC) have speculated that the agency’s new leadership will take a “lighter touch” when it comes to enforcement. The ultimate approach of the new SEC...more

3/21/2025  /  Disclosure Requirements , Enforcement Actions , Food and Drug Administration (FDA) , Insider Trading , Pharmaceutical Industry , Publicly-Traded Companies , Securities and Exchange Commission (SEC) , Securities Fraud , Securities Regulation

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
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