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Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration.

Authors :
Egilman AC
Kapczynski A
McCarthy ME
Luxkaranayagam AT
Morten CJ
Herder M
Wallach JD
Ross JS
Source :
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics [J Law Med Ethics] 2021; Vol. 49 (3), pp. 456-485.
Publication Year :
2021

Abstract

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Details

Language :
English
ISSN :
1748-720X
Volume :
49
Issue :
3
Database :
MEDLINE
Journal :
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
Publication Type :
Academic Journal
Accession number :
34665102
Full Text :
https://doi.org/10.1017/jme.2021.67