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This August 2026 regulatory update focuses on the FDA finalizing three guidances addressing formal sponsor meetings, cell and gene therapy development, and therapeutic-equivalence evaluations, while issuing draft guidance on container-closure systems,...
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This July 2026 regulatory update focuses on the FDA finalizing six guidances that addresses antiviral next-generation sequencing data, psychedelic drug trials, topical corticosteroid bioequivalence, and broader cancer-trial eligibility, while issuing...
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This June 2026 regulatory update focuses on advancing innovative drug development through updated guidance on model-informed development, gene therapies, clinical trial design, and evidence generation. Key regulatory trends included increased use of AI,...
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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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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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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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December 2025 capped the year with a robust slate of FDA activity, including multiple final and draft guidances addressing labeling, safety reporting, clinical trials, and real-world evidence, alongside notable regulatory news and multiple drug and...
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Returning from the American Society of Hematology Annual Meeting in Orlando, one message was clear: hematology is entering a phase of rapid diversification. Across late-breaking abstracts, plenary sessions, and maturing follow-up data, ASH 2025 reflected...