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Invited Commentary
April 29, 2019

Gauging the Effectiveness of Medicines Safety Communications From Global Regulatory Agencies

Author Affiliations
  • 1Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
JAMA Intern Med. 2019;179(7):984-985. doi:10.1001/jamainternmed.2019.0266

In this issue of JAMA Internal Medicine, Perry and colleagues1 review the concordance of medicines safety advisories among drug regulatory authorities in Australia, Canada, the United Kingdom, and the United States during a 10-year period. Across 680 individual safety issues, the authors report significant differences in the frequency with which individual regulatory authorities issued safety advisories for drugs approved in their respective jurisdictions, ranging from 29.6% (Australia) to 52.4% (United Kingdom). The frequency with which only 1 of the 4 regulatory authorities issued a safety advisory for an individual issue ranged from 11.1% (Australia) to 20.7% (United Kingdom).

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