Ahead of public meeting, FDA signals flexibility in evaluating smoking cessation treatments

Food and Drug Administration leaders are signaling new flexibility in the agency’s approach to evaluating new therapies to help people stop smoking.

In a perspective paper published with the National Institutes of Health this week, the agency labeled the effort to help Americans quit smoking a top priority and said it was willing to consider broader endpoints in clinical trials of smoking cessation products.

The two health agencies will hold a public meeting on Monday to discuss their regulatory approach for smoking cessation therapies going forward.

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