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FDA Advisory Committee Panelists React To Plan B “Not Approvable” Letter

This article was originally published in The Tan Sheet

Executive Summary

Four current and former FDA panelists participated in May 7 interviews with "The Tan Sheet" to discuss FDA's "not approvable" letter regarding Barr Labs' OTC switch application for the Plan B (levonorgestrel) emergency contraceptive. Below are excerpts from conversations with Nonprescription Drugs Advisory Committee member Alastair Wood, MD, Vanderbilt University Medical Center; NDAC guest consultant James Trussell, PhD, Princeton University; Reproductive Health Drugs Advisory Committee member David Hager, MD, University of Kentucky; and former NDAC Chairman Randy Juhl, PhD, University of Pittsburgh.

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