Actual Use, Label Comprehension Guidances Slated For 2006
This article was originally published in The Tan Sheet
Guidances under development in 2006 reflect FDA's interest in improving the quality of Rx-to-OTC switch submissions
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The Office of Nonprescription Products' goal of completing all OTC monographs by 2010 is viable only if FDA improves its document clearance process, according to ONP head Charles Ganley, MD
Rx-to-OTC switch sponsors will be expected to work with FDA to establish predefined endpoints for each consumer behavior trial they plan, if the agency follows advice given by the Nonprescription Drugs Advisory Committee during a Sept. 25 meeting
FDA's Nonprescription Drugs Advisory Committee will convene Sept. 25 to "consider issues related to the analysis and interpretation of consumer behavior studies conducted to support marketing" of OTCs