by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. This draft guidance document, when finalized...
by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office ISCT hosted the 20th FDA CTLM on December 8, 2023 with over 45 participants, comprised of representatives from AABB, ASFA, ASTCT, CAP, CBA, FACT, FDA/CBER/OTP/OCTHT/OGT/OCBQ/OCOD, ISCT, NHLBI, NMDP, SITC, USP, WMDA. ...
by Author: Darshan Patel, MS Fred Hutch Cancer Center United States Editor(s): Joseph Schwartz, MD, MPH Moffitt Cancer Center and Research Institute United States Crystal Ruff, PhD, MBA Takeda United Kingdom FDA CDER’s...
North America Legal and Regulatory Affairs Watchdog Update June 2022 By: Kaitlin Morrison, PhD Director of UNC Lineberger Sponsored Clinical Research, UNC Lineberger Comprehensive Cancer Center Assistant Professor of Medicine- Hematology, University of North Carolina- Chapel...
North America Legal and Regulatory Affairs Watchdog Update February 2022 By: Mo Heidaran, PhD Head of Translational and Regulatory Strategy, GC Therapeutics Joseph (Yossi) Schwartz, MD, MPH Professor of Pathology, Molecular and Cell Based Medicine, Mount Sinai Health System ...