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

April 15, 2020

Morgan Lewis partner Rebecca Dandeker was quoted in an HBW Insight article about the need for the US Food and Drug Administration (FDA) to provide guidance regarding over-the-counter (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 safe and effective] data pieces,” said Rebecca in the article.

Read the full HBW Insight article >>