FDA’s Black Box Instant Replay: A Higher Standard To Remove
Pfizer’s request for leniency on Chantix will likely be shelved, but advisory committee allows exploration of regulatory area where FDA has limited experience: The rollback of safety labeling.
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FDA will present concerns on data collection and study conduct during advisory committee meeting on removing smoking cessation drug's boxed warning.
Most FDA advisory committee members vote to wait until clinical trial results are submitted, but some also say warning should be include additional adverse events.
Pfizer wants advisory committee to endorse several labeling changes for its smoking cessation drug, but FDA says decision should wait for post-marketing trial set to be completed in about a year.