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NON-CONTRACEPTIVE PRODUCT AIMED AT STD PREVENTION WOULD WARRANT ACCELERATED NDA

This article was originally published in The Tan Sheet

Executive Summary

NON-CONTRACEPTIVE PRODUCT AIMED AT STD PREVENTION WOULD WARRANT ACCELERATED NDA review because it would constitute "a very promising product" with "indications for which there [is] no satisfactory alternative," FDA Antiviral Drugs Division Director David Feigal, MD, said at an April 7 National Institutes of Health workshop. "If there was a [chemical] product that... specifically targeted HIV and allowed pregnancy, if there was preliminary data that suggested it was effective, then conceivably [such a product] might fall into [the] mechanisms" of accelerated approval by FDA, Feigal explained. He said that it was possible that the agency "could make these available to patients on a widespread basis while...waiting for the clinical trials to be completed," and suggested that randomized dose-response studies might be an appropriate Phase IV follow-up.

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