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FDA advisory committees need more focused questions, charges, Bristol exec tells NDMA.

This article was originally published in The Tan Sheet

Executive Summary

FDA ADVISORY COMMITTEE QUESTIONS, CHARGES NEED MORE FOCUS, Bristol-Myers Squibb Senior Regulatory Director Steve Knapp suggested at the Nonprescription Drug Manufacturers Association annual Research & Scientific Development Conference in Washington, D.C. Nov. 13-14. Knapp cited the example of BMS' recent advisory committee meeting for a migraine indication for Excedrin Extra Strength in which one question put to the committee by FDA was "Is this an appropriate OTC indication?" ("The Tan Sheet" July 21, p. 8). Knapp suggested the question could have been reformulated in "such a way as to allow a focus to the discussion," for example, "Is there a more specific subpopulation that can safely select and use this product in a supervised setting?"
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