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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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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...
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Developing advanced therapies for neurology is often described as a “perfect storm of complexity.” These studies face scientific, operational, and ethical challenges that require careful planning from the earliest stages.
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In life, specialized knowledge is required when guesswork is not an option.
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January 2026 regulatory updates underscored evolving AI-focused policies, ongoing scrutiny of evidentiary standards, strengthened compliance expectations, several product approvals, and advanced review modernization initiatives. The month also introduced...
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Each rare disease may affect only a few thousand, or even a few dozen, people worldwide. Yet together, rare conditions impact millions of patients and families. Developing effective therapies for these populations is one of the most complex and...