HeyJaredJoanne S. Hawana
- Indexed articles, last 90 days
- 3
- Latest publication
- Sep 18, 2026
- Outlet visibility, for Mondaq
- Top 500K sites
- Earliest in this view
- Jul 30, 2026
Latest articles
FDA In Flux — September 2026 Newsletter (opens the original)
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Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies. What is happening: In August, FDA’s Center for Devices and Radiological Health (CDRH), through its Digital Health Center of Excellence, published a discussion paper titled “Considerations for the Regulation of Generative AI-Enabled Medical Devices.” The paper seeks early input from stakeholders on
FDA In Flux — August 2026 Newsletter (opens the original)
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Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies. What is happening: Earlier this summer, the Department of Health and Human Services (HHS) released “Operation TrialBlazer,” a sweeping roadmap designed to accelerate US-based clinical research and reverse what the Trump administration characterizes as a growing competitive threat from abroad (“the
FDA’s Advisory Committee Votes On Peptides: What It Does And Doesn’t Do (opens the original)
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A hastily reassembled Pharmacy Compounding Advisory Committee (PCAC) held meetings on July 23 and 24, 2026 to consider whether seven unapproved peptides should be included on an affirmative list of bulk ingredients that can be used by compounding pharmacies operating under the Food, Drug, & Cosmetic Act’s (FD&C Act) Section 503A (503A compounders). A second PCAC meeting to discuss an additional five peptides is expected to be scheduled in February 2027. In close votes over the course of July’s t
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