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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...
China is rapidly becoming one of the most influential forces in global drug development—but bringing innovative therapies to patients worldwide requires more than scientific progress. It requires a regulatory strategy built for global success.
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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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Following the political agreement of 11 December 2025 on the EU Pharmaceutical Package, the summary below highlights the elements most relevant to clinical evidence generation and Joint Clinical Assessment (JCA) planning. This reform represents the most...