Topical STD/vaginal contraceptive drug studies described in FDA "Points to Consider".
This article was originally published in The Tan Sheet
Executive Summary
TOPICAL STD/VAGINAL CONTRACEPTIVE DRUGS POINTS TO CONSIDER document recommends one-year toxicity studies in non-rodent species to support Phase II/III trials. In addition, six-month rodent studies are suggested for the drugs, which are considered for regulatory purposes to be chronically administered. The full title of FDA's recently-issued document is "Points to Consider in the Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives."