Comparison of Clinical Evidence Submitted to the FDA and EMA for Cell and Gene Therapies.

Elsallab, MagdiMagdiElsallabGillner, SandraSandraGillnerBourgeois, Florence TFlorence TBourgeois2025-03-122025-03-122025-04https://boris-portal.unibe.ch/handle/20.500.12422/204712This cross-sectional study compares how sponsors approach parallel submissions of gene and cell therapy applications to drug regulatory agencies.en300 - Social sciences, sociology & anthropology::350 - Public administration & military science600 - Technology::610 - Medicine & healthComparison of Clinical Evidence Submitted to the FDA and EMA for Cell and Gene Therapies.article10.48620/858913989930310.1001/jamainternmed.2024.7569