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A Congressional Research Service In Focus brief reviews the three gene therapies FDA approved since 2023 for sickle cell disease, thalassemia, and hemophilia A, and suggests Congress look at long-term risk monitoring and sponsor reporting.
Why it’s here: A CRS report on FDA regulation of novel gene therapies (CRISPR, lentiviral, AAV) with explicit congressional considerations falls squarely within biotechnology policy.
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Oct 25CongressA Congressional Research Service In Focus brief reviews the three gene therapies FDA approved since 2023 for sickle cell disease, thalassemia, and hemophilia A, and suggests Congress look at long-term risk monitoring and sponsor reporting.BiotechDetails1 linked
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1 links- HillEarly-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry; AvailabilityBoth involve Food and Drug Administration, Center for Biologics Evaluation and Research
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