Pink Sheet 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

L’Oreal Falls Short On Safety, Efficacy, Adverse Event Data

This article was originally published in The Tan Sheet

Executive Summary

FDA says it needs additional data from L’Oreal on safety, efficacy and adverse events to determine GRASE for drometrizole trisiloxane.

You may also be interested in...



Adverse-Event Data Requirement Among Sunscreen TEA Bugs – FDA

The significant time and resources necessary to amend the monograph are one reason for FDA’s slow response to time and extent applications to add ingredients to the OTC sunscreen monograph, agency officials say. Another reason may be flawed data requirements in the application process, with the requirement for adverse-event reports cited as a particular challenge for both sponsors and the agency.

Senators Optimistic As Sunscreen Bill Heads For HELP Committee Markup

Ahead of a Sept. 17 committee markup of the Senate’s Sunscreen Innovation Act, bill sponsors and stakeholders held a briefing on Capitol Hill to generate support for the legislation, which has already passed in the House. The bill, S. 2141, has 15 co-sponsors and is expected to advance through committee to the Senate floor.

Flaws In TEA Process Delay Reviews, Monograph Changes – FDA

The significant time and resources necessary to amend the monograph are one reason for FDA’s slow response to time and extent applications to add ingredients to the OTC sunscreen monograph, agency officials say. Another reason may be flaws in data required in the application process.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS107143

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