US OTC Monograph Reform's Early Results Could Be Label Orders from FDA, Wait and See for Industry, HBW Insight

Morgan Lewis partner Rebecca Dandeker was quoted in a HBW Insight article about the need for the US Food and Drug Administration to provide guidance regarding OTC monographs. "The standard for establishing the safety and effectiveness of this new ingredient or this new dosage form remains the same. … But what is more complex is that FDA now will be reviewing and potentially passing judgement about each and every one of those [generally regarded as safety and effective] data pieces," said Rebecca in the article.

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