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


Gingivitis comment deadline

This article was originally published in The Tan Sheet

Executive Summary

FDA should extend the deadline for comments on draft guidance for OTC gingivitis drug products from Aug. 29 to Oct. 28, the Consumer Healthcare Products Association requests in a July 15 submission to the agency. The extra 60 days will allow time "to coordinate an industry response and to provide the agency with meaningful and substantive comments," CHPA says. The draft guidance, published June 28, focuses on clinical trials design issues for OTC and Rx gingivitis treatments (1"The Tan Sheet" July 4, 2005, In Brief)...

You may also be interested in...

FDA gingivitis guidance

OTC gingivitis products should carry the labeling claim "helps prevent gingivitis" while Rx drugs may include the more scientific phrase "reduction of disease incidence," FDA recommends in a FDL-1draft guidance published in the Federal Register June 28. "Gingivitis: Development & Evaluation of Drugs for Treatment or Prevention" focuses on trial design issues and clinical assessments involved with developing both Rx and OTC products for the condition. Recommended inclusion criteria for clinical trials such as "a specified number of teeth present" and "a qualifying baseline plaque index" are provided by the agency, while exclusion criteria include "chronic disease with concomitant oral manifestations." A definition of the difference between prevention and treatment of the condition also is included...

Catchup Capsule: Key APAC Insights You Need To Read

Given its ever-growing role as a critical component of the global biopharma industry, you can’t afford not to be up to speed on Asia. This selection of recent insights from our experienced on-the-ground team will help.

US FDA Addresses PFAS In Cosmetics, Aiming To Close Data Gaps

Use of per- and polyfluoroalkyl substances in cosmetic products appears to be declining, based on voluntary industry registrations with the US Food and Drug Administration. In any event, NGOs are gunning for PFAS' elimination, and the FDA says available data have yet to give a complete safety picture for PFAS used intentionally in cosmetics or present as impurities.





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