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Global Regulatory Agencies and Data Transparency

Published online by Cambridge University Press:  19 October 2021

Caroline F. Plott  and
Joshua M. Sharfstein
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Abstract

Egilman et al. review the current data sharing practices of three global regulatory agencies — Health Canada, the European Medicines Agency and the Food and Drug Agency. While there has been progress towards increasing transparency over the past decade, progress has been slow.

Keywords

TransparencyRegulatoryDataFDAEuropean Medicines AgencyHealth Canada
Type
Independent Articles: Commentary
Information
Journal of Law, Medicine & Ethics , Volume 49 , Issue 3: Malingering & Health Policy , Fall 2021 , pp. 486 - 488
Copyright
© 2021 The Author(s)

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References

FDA, “FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability,” Federal Register Web site, available at <https://www.federalregister.gov/documents/2010/05/21/2010-12314/fda-transparency-initiative-draft-proposals-for-public-comment-regarding-disclosure-policies-of-the> (last visited July 26, 2021); Bonini, S., Eichler, H., Wathion, N., and Rasi, G., “Transparency and the European Medicines Agency — Sharing of Clinical Trial Data,” New England Journal of Medicine 371, no. 26 (2014): 2452–2455, available at <https://doi.org/10.1056/NEJMp1409464> (last visited July 26, 2021); Health Canada, “Regulatory Transparency and Openness Framework and Action Plan 2015-2018,” Government of Canada Web site, available at <https://www.canada.ca/en/health-canada/corporate/transparency/regulatory-transparency-and-openness/regulatory-transparency-openness-framework-action-plan-2015-2018.html> (last visited July 26, 2021).CrossRefGoogle ScholarPubMed
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