HBW Insight 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

Sunscreen TEA Advocates Want Help Clearing FDA’s ‘High Bar’ For GRASE

This article was originally published in The Rose Sheet

Executive Summary

FDA explained its “high bar” for GRASE designations awarded to ingredients in sunscreen TEAs during a public meeting on implementation of the Sunscreen Innovation Act. Industry and advocacy groups are concerned that impediments to meeting OTC monograph safety standards will squelch sunscreen ingredient innovation.

You may also be interested in...



FDA 'May Hold Private Meetings' Offer Eases Sunscreen Monograph Tension

Proposed final sunscreen monograph published in February provided more clarity for TEA sponsors to engage with agency, but May publication of final guidance on MUsT for topically applied ingredients for OTC drug monograph could motivate TEA sponsors for sunscreen and other topical active ingredients to push their proposals forward.

All Roads For OTC Policy Improvements Lead To User Fees, FDA Suggests

In an update on discussions with industry about potential user fees to support FDA's OTC monograph program, CDER officials say "industry and public would suffer" absent new fees.

Fourth Time’s A Charm? President’s FY 2016 Budget Includes Cosmetic Fees

Continuing what has become a familiar refrain, the Obama administration’s fiscal 2016 budget request for FDA includes cosmetics user fees, marking the fourth consecutive year that such a system has been proposed. Legislation would need to be introduced – and passed – in order to establish cosmetics user fees.

Related Companies

UsernamePublicRestriction

Register

RS019786

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