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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Ross JS. Evidence Supporting US Food and Drug Administration Drug Safety Communications. JAMA Intern Med. Published online September 03, 2019. doi:10.1001/jamainternmed.2019.3065
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