Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

SCCP on tooth whitener studies

This article was originally published in The Tan Sheet

Executive Summary

Guidance on product application, end points, size and definition of study populations, including subgroup, and study duration is included in the European Commission's Scientific Committee on Consumer Products' recently published "Guidance Document on Epidemiological and Clinical Studies on Tooth Whitening Products." The 1guidance responds to a March 2005 SCCP meeting in which the committee observed that there is an "absence of good data and long-term epidemiology studies that assess the possible adverse effects [of tooth whiteners] within the oral cavity" (2"The Tan Sheet" April 4, 2005, p. 16). Parameters such as the separate evaluation of hard and soft tissue effects and the evaluation of age groups since "differences in the degrees of mineralization of dental hard tissue may affect the treatment outcome," are also addressed...

You may also be interested in...



SCCP Upholds Opinion On Tooth Whiteners With Hydrogen Peroxide

Adequate data do not exist to support the safety of tooth-whitening products containing up to 6% hydrogen peroxide for over-the-counter use, the European Commission Scientific Committee on Consumer Products concludes in a recent opinion

Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings

Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.

Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation

Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS099459

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