Abstract— In February 2026, the FDA announced that a single pivotal phase 3 (P3) trial would become the new default standard for drug approval—a regulatory direction that had been legally enabled since the FDA Modernization Act of 1997. This announcement has...
Sheldon Preskorn, MD, Senior Vice President of Neuroscience, presented “10 Lessons Learned Over 40 Years of Drug Development Research in Psychiatry” at the 2024 CNS Summit. Dr. Preskorn provided strategies for enhancing clinical trial design, minimizing patient...
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