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

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

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.

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Bibliographische Detailangaben
Veröffentlicht in:The Journal of law, medicine & ethics medicine & ethics, 2021-01, Vol.49 (3), p.456-485
Hauptverfasser: Egilman, Alexander C., Kapczynski, Amy, McCarthy, Margaret E., Luxkaranayagam, Anita T., Morten, Christopher J., Herder, Matthew, Wallach, Joshua D., Ross, Joseph S.
Format: Artikel
Sprache:eng
Schlagworte:
Biological products
Business information
Clinical trials
Data
Disclosure
Drugs
FDA approval
Food
Health technology assessment
Information sharing
Medical device industry
Medical equipment
Product development
Product safety
Regulatory agencies
Statistical analysis
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Beschreibung
Zusammenfassung: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.
ISSN:1073-1105
1748-720X
DOI:10.1017/jme.2021.67