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

LNK labeling deferral

This article was originally published in The Tan Sheet

Executive Summary

FDA grants LNK International deferral from "Drug Facts" labeling requirements for 19 OTCs until Dec. 31. In recent letter, agency says "we intend to exercise enforcement discretion" until year end based on LNK's May 31 application for exemption. Hauppauge, N.Y. firm noted additional time would enable it "to shift to a larger or alternative package style for these products to comply" with labeling final rule, FDA says. Per LNK's request, agency conducted "cursory review" of "Drug Facts" portion of 19 OTC draft labels and found "several content and format features in the 'Drug Facts' information that are not in compliance" with final rule. FDA notes its upcoming guidance on how reference listed drug, ANDA holders can update labeling consistent with "Drug Facts" format "may be particularly helpful to your company because several of the 19 products...are ANDA ibuprofen tablets, which this guidance will specifically address"...

You may also be interested in...



Warning Letter Close-Outs – March 2020

The US FDA released five device-related close-out letters in March.

Medicines Must Be Designated As Priority Items, Says IGBA

Governments around the world should designate all medicines as ‘priority essential products’, the IGBA has urged, as a surge in demand coinciding with a reduction in the number of flights and rising freight costs are making it more difficult for suppliers to meet global requirements amid the coronavirus pandemic.

COVID-19: FDA Will Hold Remote Meetings With Firms, Extends Marketing Application Due Dates

In a letter to the medtech industry, the FDA’s William Maisel says the US agency will hold remote meetings with device makers and other stakeholders through the end of May. The FDA also extended due dates for marketing applications by 90 days.

Topics

UsernamePublicRestriction

Register

PS094824

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