Pfizer's Chantix Warning May Remain As FDA Raises Trial Concerns
FDA will present concerns on data collection and study conduct during advisory committee meeting on removing smoking cessation drug's boxed warning.
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FDA could use advisory committee members' comments to maintain the smoking cessation drug's boxed warning, even though they voted to remove it.
When industry rep questioned whether problems with smoking cession drug trial were overestimated, FDA's rebuke was swift.
Advisory committee says data supports dialing back safety label for the smoking cessation product, but shouldn’t be precedent setting.