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Editor's Note
September 3, 2019

Evidence Supporting US Food and Drug Administration Drug Safety Communications

Author Affiliations
  • 1Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut
JAMA Intern Med. Published online September 3, 2019. doi:10.1001/jamainternmed.2019.3065

The US Food and Drug Administration (FDA) is responsible for ensuring that approved drugs are safe and effective. However, the clinical trials that form the basis for FDA approval typically enroll fewer than 1000 patients and have follow-up durations of 6 months or fewer.1 Thus, most serious safety risks may only become evident after FDA approval. In fact, for approximately one-third of new drug approvals, the FDA issues a new safety communication or warning after initial approval.2

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