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For decades, oncologists and drug developers shared an undeniable truth: KRAS – one of the most commonly mutated genes in human cancer – was untargetable. Mutations in KRAS drive approximately 25% of all cancers, including most pancreatic...
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This May 2026 regulatory update highlights multiple guidances issued by the FDA across cell and gene therapy, clinical development, and pharmaceutical quality. The FDA also released new draft guidances focused on pain management, stimulant use disorders,...
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Key insights from my presentation at the AMWA Carolinas Spring 2026 Conference on the evolving global expectations for patient-facing clinical content
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Best Practices for Safety Narrative Writing in Clinical Research
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This April 2026 regulatory update highlights new policies on biomarker validation, expanded access to investigational drugs, genome editing safety assessments, and antibiotic impurity specifications. It also summarizes major FDA and industry...
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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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March 2026 regulatory updates underscore newly published final and draft guidances focused on real-world data, safety reporting, biosimilars, CGMP inspections, and innovative drug development methods. It also highlights industry news and regulatory...
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In February 2026, FDA activity included new draft guidances, regulatory initiatives (e.g., PreCheck and eCTD 4.0), continued focus on innovation areas like rare diseases and AI, multiple drug approvals (including new molecular entities), and an upcoming...