Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

OTC vaginal spermicide feedback meeting

This article was originally published in The Tan Sheet

Executive Summary

"Will be useful to discuss such topics as dose-ranging studies, study protocols, and in vivo and in vitro testing needed to demonstrate comparative safety and efficacy," FDA tells NDMA in a June 3 letter. The agency urged industry to establish the optimal dose range for nonoxynol-9 spermicide products in a Nov. 7 feedback letter ("The Tan Sheet" Dec. 1, 1997, p. 13). "Our recommendations for dose-ranging studies would allow manufacturers whose OTC dose/dosage form was not part of the NICHD study, to conduct comparative clinical trials using the optimal dosing range and, perhaps, to bridge the results to other relevant clinical data," FDA explains. The agency adds, however, the final marketing status of an OTC vaginal spermicide depends on its meeting FDA standards whether through the monograph or NDA process...
Advertisement
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS088564

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel