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

Sunscreen claims, OTC labeling

This article was originally published in The Rose Sheet

Executive Summary

FDA's latest public estimate of when it will issue a proposed rule on sunscreen UVA/UVB claims is April 2003, according to the agency's 1unified agenda, appearing in the May 13 Federal Register. The target date is beyond previous indications from the agency that amendment to sunscreen final monograph would be published before the end of 2002. Agenda targets December for release of proposal providing flexibility for labeling of small one- or two-dose "convenience" size OTC drugs. While rulemaking proceeds, such products are excused from complying with OTC drug labeling requirements (2"The Rose Sheet" April 8, 2002, p. 10). Current OTC review agenda is more abbreviated than usual; FDA decided to list only those actions expected to be completed within next 12 months, the agency said...

Latest Headlines
See All
UsernamePublicRestriction

Register

RS010305

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