Advisory Semantics: When Words Get In The Way Of Science At FDA Panels

Industry experts offer advice on how sponsors can prevent advisory committee meetings from going awry due to confusing questions; some suggest eliminating votes actually may create clearer panel outcomes.

The order, wording and meaning of questions at FDA advisory panels potentially can affect the outcome of the meeting – and perhaps whether a drug ultimately is approved or nixed by the agency.

With 2014 underway and at least 50 new products already under review, dozens of new drug and biologic candidates will head to the advisory committee process before a final FDA

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