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

Gingivitis comments

This article was originally published in The Tan Sheet

Executive Summary

FDA's draft guidance on gingivitis products "attempt[s] to establish certain standards for the design and evaluation of studies that go further than scientifically and clinically desirable and appropriate," Church & Dwight states in Oct. 27 comments to the agency. The guidance was released in June by FDA to aid sponsors with developing Rx and OTC products to treat gingivitis. "When standards are set unnecessarily and inappropriately high, useful products whose benefits exceed their risk cannot come to market," C&D adds. In a separate submission, J&J suggests specifying blinded trial requirements and revising the phrasing of inclusion/exclusion criteria. The Consumer Healthcare Products Association also submitted comments in October (1"The Tan Sheet" Nov. 7, 2005, p. 10)...
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS098825

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