Industry Wants Easier Path For OTC Drug Monograph, Labeling Changes
This article was originally published in The Rose Sheet
Three over-the-counter drug marketers say FDA should develop an easier pathway for minor changes to OTC drug monographs in comments submitted to the agency. Providing input on how the agency can make its OTC drug review process more agile and efficient, the firms propose mechanisms for dosage-form variations and adding warnings to Drug Facts boxes on product labeling.
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