9 min read
Monthly FDA Guidance and Regulatory News Review - March 2026
March 2026 regulatory updates underscore newly published final and draft guidances focused on real-world data, safety...
We understand how high the stakes are with gene therapy programs, and that nothing is standard about the study design, study conduct or regulatory process. Join us at the 4th Annual Gene Therapy for Rare Disorders Europe to learn about the manufacturing, clinical, and commercialization challenges drug developers face when bringing gene therapies to market.
Join to hear Veristat discuss our gene therapy expertise across the clinical development pathway including how we:
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October 27, 2020 at 12:00 PM GMT
Speaker: Rachel Smith, Project Director, Veristat
Veristat joins the discussion covering how to choose the most suitable comparator, utilize natural history studies effectively, and use appropriate controls.
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October 27, 2020 at 3:00 PM GMT
Host: Mindy Leffler, President & Chairman, Casimir, Panelist: Ewan Campbell, Advanced Therapy & Biotech Director, Veristat
Visit the conference website to register or learn more:
9 min read
Apr 6, 2026 Veristat Blog
March 2026 regulatory updates underscore newly published final and draft guidances focused on real-world data, safety...
7 min read
Mar 27, 2026 Veristat Blog
In February 2026, FDA activity included new draft guidances, regulatory initiatives (e.g., PreCheck and eCTD 4.0),...