Pink Sheet 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

“Grandfathered” Category Of “Convenience-Size” OTCs Sought By GSK

This article was originally published in The Tan Sheet

Executive Summary

FDA's rule partially delaying implementation of OTC labeling requirements for certain "convenience-size" drugs should be amended to include a category of "grandfathered" products, GlaxoSmithKline says in an Oct. 25 citizen petition

You may also be interested in...



OTC “Convenience-Size” Two-Dose Rule Should Allow For Exemptions – CHPA

FDA should extend its classification of "convenience-size" OTCs beyond the two-dose limit outlined in a recent rule partially delaying "Drug Facts" labeling compliance for such products, the Consumer Healthcare Products Association says

OTC Labeling Compliance Date Delayed For “Convenience-Size” Items

"Convenience-size" OTC drugs will not be required to meet "Drug Facts" reg compliance dates until FDA publishes either a final rule or further notice on the labeling of such products

Block Exemption Request Differentiates "Label" From "Labeling"

Block Drug's request for an exemption from the OTC labeling final rule for its BC analgesic powder complies with provisions of the FD&C Act that differentiate a product's "label" from product "labeling," the company says in a Dec. 22 letter to FDA.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS094764

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