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Michele L. Buenafe on Muck Rack

Michele L. Buenafe

Washington, D.C.
As seen in: Bloomberg Law, Law360, JD Supra, The National Law Review, Lexology, Mondaq, Westlaw Today, Med Device Online, Law360 UK
Regulatory lawyer in #digitalhealth, #MedTech, life sciences @MorganLewisLaw. Tweets my own views, not Firm or clients. RT/like ≠ endorsement. She/Her/Hers.
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Articles

Industry Confidence In FDA May Hinge On CBER, CDER Leadership, Inside Health Policy

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By Michele L. Buenafe, Maarika L. Kimbrell
| morganlewis.com
Inside Health Policy spoke with FDA & Healthcare practice group leader Michele L. Buenafe and partner Maarika L. Kimbrell about the operational and regulatory challenges facing the US Food and Drug Administration amid significant leadership turnover and staffing declines across the agency. Michele emphasized the importance of stable leadership within FDA’s centers to support effective operations and long-term planning.
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Accelerated Psychedelic Therapy Pathways Require Caution

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By Michele L. Buenafe, Jacqueline R. Berman
| Law360 Verified
By Michele Buenafe and Jacqueline Berman ( May 11, 2026, 4:03 PM EDT) -- On April 18, President Donald Trump issued an executive order aiming to facilitate the development and approval of psychedelic drugs for the treatment of mental health disorders.... Law360 is on it, so you are, too. A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence.
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You Are Not Hallucinating: Executive Order Aims to Accelerate Approval of Therapeutic Psychedelics

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By Jacqueline R. Berman, Michele L. Buenafe
| JD Supra
On April 18, 2026, President Trump issued an executive order on Accelerating Medical Treatments for Serious Mental Illness, aiming to facilitate the development and approval of psychedelic drugs for the treatment of mental health disorders. While psychedelics have shown significant promise for the treatment of such disorders as post-traumatic stress disorder, mood disorders, and addiction, they face a number of development challenges.
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