The Food and Drug Administration is showing increased flexibility in its evaluation of new therapies for smoking cessation. In collaboration with the National Institutes of Health, the FDA has labeled efforts to help Americans quit smoking a top priority and is open to considering broader endpoints in clinical trials for smoking cessation products. The agencies will hold a public meeting to discuss their regulatory approach for these therapies moving forward. This shift in approach indicates a willingness to explore new methods and strategies to support individuals in their efforts to quit smoking.
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FDA signals flexibility in evaluating smoking cessation therapies
