Pink Sheet is part of the Business Intelligence Division 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

FDA Proposes Illuminating OTC Monograph Process With Sunscreen TEA Framework

This article was originally published in The Tan Sheet

Executive Summary

A proposed rule that sets deadlines for multiple steps in its reviews of TEAs for OTC ingredients should make the monograph process more transparent to the industry, but a timeline for sunscreen ingredient TEAs, as required by the Sunscreen Innovation Act, has not opened a door on application approvals.

Advertisement

Related Content

OTC Monograph Application Reviews Get Deadlines, Not GRASE Flexibility
OTC Monograph User Fees: FDA-Industry Talks Move From Basics To Details

Topics

Advertisement
UsernamePublicRestriction

Register

PS108255

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