Comparison of Clinical Evidence Submitted to the FDA and EMA for Cell and Gene Therapies
This cross-sectional study compares how sponsors approach parallel submissions of gene and cell therapy applications to drug regulatory agencies.
Authors
- Magdi Elsallab (ORCID: https://orcid.org/0000-0001-9574-3496)
- Florence T. Bourgeois (ORCID: https://orcid.org/0000-0001-7798-4560)
- S Gillner (ORCID: https://orcid.org/0009-0004-8842-4437)
Institutions
- University of Bern (CH)
- Boston Children's Hospital (US)
- Harvard University (US)
- Massachusetts General Hospital (US)
Publication Details
- Journal
- JAMA Internal Medicine
- Published
- 2025-02-03
- DOI
- https://doi.org/10.1001/jamainternmed.2024.7569
- Citations
- 2
- Primary Topic
- Biomedical Ethics and Regulation
- Type
- article
- Field-Weighted Citation Impact
- 2.33