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Opill AdCom Delay Not Unusual – Will Evaluation Of US OTC Switch Proposal Continue In The Norm?

Executive Summary

Whether FDA handling of HRA Pharma’s OTC switch NDA for 0.075-mg norgestrel continues along normal arc is question which prompts concerns. “I hope that they don't make the same mistakes that were made back on the Plan B,” says Susan Wood, an associate professor at George Washington University School of Public Health and a former FDA office director.

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