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When an oncology drug is tested, the signal is often brutally clear. A tumor either shrinks on a scan or it does not. A patient either lives or does not. In psychiatric drug development, the endpoints are almost never so crisp. In PTSD trials in...
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In August 2024, the FDA declined to approve MDMA-assisted therapy for post-traumatic stress disorder. The decision followed a June advisory committee meeting in which panelists voted nine to two that the data had not shown MDMA was effective, and ten to...
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It was wonderful to connect with so many of our peers at RAPS Convergence 2025 in Pittsburgh. As the largest annual gathering of regulatory professionals, the event brought together more than 2,000 experts across pharmaceuticals, biologics, devices, and...
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Developing treatments for neurological, psychiatric, or CNS disorders means navigating complex trial designs, subjective endpoints, and global variability, all under tight timelines. These complexities must be translated into submissions that regulators...