OTC spermicides monograph should be based in part on forthcoming NICHD data -- NDMA.
This article was originally published in The Tan Sheet
Executive Summary
SPERMICIDES MONOGRAPH BASED IN PART ON NICHD TRIAL URGED BY NDMA in a "position paper" submitted to FDA Nov. 4. The products used in the planned National Institute of Child Health & Human Development trial could be employed by the United States Pharmacopoeia to develop a reference standard system for OTC spermicides, and data from the study could "be reviewed by FDA and incorporated into the final monograph," the Nonprescription Drug Manufacturers Association suggested.