FDA утвердила новые правила регистрации генетических лекарств

Newsletter | July 6, 2026 FEATURED ARTICLE Understanding FDA's Plausible Mechanism Framework For Genetic Medicines FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster. INDUSTRY INSIGHTS FSP Resources Driving Efficiency And Optimized Outcomes FSP partnerships are transforming clinical operations and delivering not only efficiency and scalability, but also the innovation needed to accelerate development and improve patient outcomes. Contamination Control Strategies In Low Bioburden Manufacturing Annex 1’s updated CCS framework calls for a holistic contamination strategy. Learn how manufacturers can apply it to non-sterile sites and legacy facilities using tailored risk-based approaches. Best Practices For Building A Multi-Product Manufacturing Multi-product ATMP facilities need integrated teams, flexible design, and strategic HVAC to ensure scalability, contamination control, cost efficiency, and reliable long-term performance. Digital Process Twin Cuts J&J Production Time And Costs Virtual process modeling is helping to cut production time, reduce solvent use, and improve sustainability. Learn how digital twins enable faster scale‑up decisions and more efficient manufacturing. Rethinking Trial Access Through Trust-Driven Design And Local Collaboration Locally embedded research models help sponsors reach underserved populations while reducing burden on patients and health systems alike.