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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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Butrans Pediatric Labeling Draws Mixed Views At US FDA Panel

Opponents say including data from a small pediatric trial of Purdue's buprenorphine patch could give the impression the study was more robust than it actually was, while supporters say labeling should reflect any available data that can inform pediatric prescribing.

GSK's Shingrix Shingles Vaccine Awaiting Final Labeling Tweaks

US advisory committee unanimously impressed by the 90% plus efficacy; FDA says label may note lack of data in those who've previously had shingles.

Opioid Cough Restrictions: Pediatric Use, And Postmarket Studies, Likely Limited

US FDA advisory committee strongly recommends antitussives containing codeine or hydrocodone not be used by patients under age 18 years old, pointing to lack of modern evidence of benefit and known risks of respiratory depression and misuse. Expanding the contraindicated population could get some product sponsors off the hook for required pediatric studies.

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