NDMA requests feedback meeting on its research plan for OTC spermicides.
This article was originally published in The Tan Sheet
Executive Summary
FDA DISCUSSION OF SPERMICIDE BIOACTIVITY TESTING for comparisons with the U.S. Pharmacopeial reference standard is requested by the Nonprescription Drug Manufacturers Association in March 3 comments to the agency. NDMA asks for a "feedback" meeting with FDA to discuss several aspects of its proposed research plan to continue OTC availability of spermicides, including appropriate in vitro and in vivo bioactivity testing to be used to compare products with a USP reference standard.
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