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FDA's draft guidance on gingivitis products "attempt[s] to establish certain standards for the design and evaluation of studies that go further than scientifically and clinically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)...

You may also be interested in...



CTFA/CHPA Urge More Flexibility in Gingivitis Draft Guidance

FDA's draft guidance for antigingivitis drug development and evaluation should encourage the creation of new indices that provide "meaningful and clinically relevant measures" of gingivitis, according to industry trade groups

Teva Debuts US Azopt Rival

Teva has launched the first and so far only US generic version of Novartis’ Azopt treatment for ocular hypertension, with the brinzolamide 1% solution having been developed and manufactured by Indoco Remedies.

EU MDR Notified Body Designations Could Soar By A Third By End Of 2021

There could be 28 notified body designations in total under the Medical Device Regulation by the end of 2021. But there is cause for concern over designations under the IVD Regulation, which are lagging far behind.

Topics

UsernamePublicRestriction

Register

OM016276

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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