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

OTC Trade Dress, Columns Possible Exemption Requests - FDA's Ganley

This article was originally published in The Rose Sheet

Executive Summary

Trade dress and the use of columns to present required label information would be two "interesting" areas for which industry could submit exemption requests under the OTC labeling rule, FDA Division of OTC Drugs Director Charles Ganley, MD, said at the Regulatory Affairs Professionals Society annual meeting in Washington, D.C. Oct. 5.

You may also be interested in...



CHPA Requests Two-Year Extension For OTC Labeling Final Rule

A two-year extension of the implementation deadlines for FDA's final rule on over-the-counter drug labeling is requested by the Consumer Healthcare Products Association in a citizen petition submitted to the agency Oct. 1.

CHPA Requests Two-Year Extension For OTC Labeling Final Rule

A two-year extension of the implementation deadlines for FDA's final rule on over-the-counter drug labeling is requested by the Consumer Healthcare Products Association in a citizen petition submitted to the agency Oct. 1.

Trade Dress Exemption Could Be Short-Term Fix To OTC Label Issues - CTFA

A general exemption for OTC products that meet a "clear and conspicuous" performance standard may be an "intermediate fix" for those that do not meet the color requirements in the OTC labeling rule, Cosmetic, Toiletry and Fragrance Association VP-Legal & General Counsel Thomas Donegan said. He spoke at an FDA working group meeting to discuss product labeling in Rockville, Md. Aug. 24.

Latest Headlines
See All
UsernamePublicRestriction

Register

RS007246

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