HBW Insight 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

PASS Coalition Works Toward FDA Acceptance Of New(ish) UV Filters

This article was originally published in The Rose Sheet

Executive Summary

The newly formed Public Access to Sunscreens coalition says it plans to work with FDA, legislators and stakeholders to facilitate review of sunscreen actives. The group proposes user fees as one method of ensuring FDA has the resources it needs to complete sunscreen ingredient evaluations, some of which have been pending as time and extent applications since 2002.

You may also be interested in...



FDA Floats OTC Monograph Overhaul To Be “More Agile And Responsive”

The agency will conduct a public hearing March 25-26 to garner input on improving the OTC monograph process, which currently faces “significant challenges.” FDA’s proposals include expanding the process for allowing deviations from formulations approved through NDAs and issuing monographs by administrative order.

Reps Prep Sunscreen Filter Legislation; FDA Frustrated By Backlog

Without swift FDA action on eight sunscreen filters pending review, legislators intend to introduce a bill to alter the agency’s sunscreen approval process. House members questioned FDA Center for Drug Evaluation and Research Director Janet Woodcock on the status of the applications, some of which have been under agency review for more than 10 years.

CDC Should Help Spur FDA’s Sunscreen Filter Review – PASS Coalition

Consumers would be better equipped against harmful UV radiation if they had access to next-generation sunscreen actives mired in FDA’s Time and Extent Application process, the Public Access to Sunscreens Coalition suggests in comments to the Centers for Disease Control and Prevention. The Personal Care Products Council also submitted comments emphasizing the importance of sunscreen use.

Related Content

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

RS018570

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