by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT)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 This draft guidance document, when finalized...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 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 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...