National regulatory agencies’ decisions to approve new drugs are based on limited safety evidence collected during clinical development. Often, only when a drug enters general use do rarer or longer-term adverse events become known or better understood, prompting regulators to issue safety advisories.1 We examined how often medicines regulators in 4 countries with similar medical traditions, population health, and demographics—Australia, Canada, the United Kingdom, and the United States—were concordant in their decisions to issue safety advisories on approved prescription medicines.
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Perry LT, Bhasale A, Fabbri A, et al. Comparative Analysis of Medicines Safety Advisories Released by Australia, Canada, the United States, and the United Kingdom. JAMA Intern Med. Published online April 29, 2019. doi:10.1001/jamainternmed.2019.0294
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