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

Final OTC Sunscreen Monograph Postponed, FDA Leadership Confirms

Executive Summary

The US FDA is still working through more than 20,000 comments on its February proposed rule to establish a final OTC sunscreen drug monograph. Thus, it will not meet the 26 November 2019 deadline set by the Sunscreen Innovation Act of 2014, said Theresa Michele, director of FDA’s nonprescription drug division, during a 21 November public meeting with industry advocates.

You may also be interested in...



Cosmetics Market In 2019: CBD, Microplastic And US Sunscreen Uncertainty Among Year’s Biggest Issues

The opportunity represented by cannabidiol, and the uncertain future for commonly used sunscreen active ingredients in the US and microplastic in the EU, were issues of high interest among cosmetics industry stakeholders in 2019.

FDA Plans To Publish 'Novel' OTC Switch NPRM In May 2020

Agency list in HHS Unified Agenda also states intent to publish before end of 2019 an NPRM to add the common cold indication to certain OTC monograph antihistamine ingredients. Nonbinding timelines also included for NPRM on clarifying regarding when studies to evaluate drug uses of products marketed as foods, supplements or cosmetics are subject to IND reviews.

FDA, PCPC To Meet On Sunscreen Work Plan; Industry’s ‘Extended’ Study Timelines A Possible Topic

The US FDA’s deferral of final GRASE rulemaking on UV filters identified in its February proposed rule as lacking data hinges on its acceptance of industry’s work plan. In October, the agency expressed concerns about the plan submitted by the Personal Care Products Council, but granted the group’s request for a meeting – slated for 13 November – to discuss the issues further.

Related Content

Topics

UsernamePublicRestriction

Register

RS149446

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