Comparison of Clinical Evidence Submitted to the FDA and EMA for Cell and Gene Therapies.
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BORIS DOI
Date of Publication
April 2025
Publication Type
Article
Division/Institute
Author
Elsallab, Magdi | |
Bourgeois, Florence T |
Series
JAMA Internal Medicine
ISSN or ISBN (if monograph)
2168-6114
2168-6106
Publisher
American Medical Association
Language
English
Publisher DOI
PubMed ID
39899303
Description
This cross-sectional study compares how sponsors approach parallel submissions of gene and cell therapy applications to drug regulatory agencies.
File(s)
| File | File Type | Format | Size | License | Publisher/Copright statement | Content | |
|---|---|---|---|---|---|---|---|
| jamainternal_elsallab_2025_ld_240037_1736873900.12889.pdf | text | Adobe PDF | 148.57 KB | Publisher holds Copyright | published |