FDA EXAMINING "COHESIVE" OTC ANALGESIC POLICY FOR MONOGRAPH AND NDAed DRUGS
This article was originally published in The Tan Sheet
FDA EXAMINING "COHESIVE" OTC ANALGESIC POLICY FOR MONOGRAPH AND NDAed DRUGS, the agency notes in a background document developed in preparation for the Sept. 8-9 meeting of a newly formed subcommittee comprised of members of FDA's Nonprescription Drugs and Arthritis Advisory Committees. The subcommittee meeting "will focus on effectiveness data requirements and pain indications for both OTC monograph and NDA-switch products," the document states.
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