In Vivo 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 Labeling Trade Dress Issue Resolved In FDA Technical Amendment

This article was originally published in The Rose Sheet

Executive Summary

Labeling of over-the-counter drug products may include light type on a dark background providing the combination results in a highly readable contrast, FDA asserts in a technical amendment to the OTC label reform rule published in the Jan. 3 Federal Register.

You may also be interested in...



OTC trade dress

CTFA supports FDA's technical amendment to OTC labeling rule, which loosens trade dress guidelines and allows use of dark-on-light and light-on-dark type. "The amended version of the final rule provides appropriate recognition of the value of trade dress" for manufacturers and consumers, the trade group says in March 17 comments. In previous verbal and written arguments, CTFA maintained that as originally drafted, the reg would restrict product distinctiveness. FDA granted the amendment in January (1"The Rose Sheet" Jan. 10, p. 9)

OTC trade dress

CTFA supports FDA's technical amendment to OTC labeling rule, which loosens trade dress guidelines and allows use of dark-on-light and light-on-dark type. "The amended version of the final rule provides appropriate recognition of the value of trade dress" for manufacturers and consumers, the trade group says in March 17 comments. In previous verbal and written arguments, CTFA maintained that as originally drafted, the reg would restrict product distinctiveness. FDA granted the amendment in January (1"The Rose Sheet" Jan. 10, p. 9)

OTC Drug Labeling Implementation Date Extended One Year To 2002

FDA is extending the OTC drug labeling implementation date to May 2002 to allow time for the agency to develop "forthcoming guidances" regarding a number of outstanding concerns from trade organizations.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

RS007540

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