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FDA's draft guidance on gingivitis products "attempt[s] to establish certain standards for the design and evaluation of studies that go further than scientifically and clinically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CTFA/CHPA Urge More Flexibility in Gingivitis Draft Guidance
FDA's draft guidance for antigingivitis drug development and evaluation should encourage the creation of new indices that provide "meaningful and clinically relevant measures" of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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: