Pink Sheet is part of the Business Intelligence Division 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

NDAed OTC product exemption from FDA OTC labeling rule sought by J&J/Merck.

This article was originally published in The Tan Sheet

Executive Summary

NDAed OTCs SHOULD BE EXEMPT FROM FDA LABELING RULE, J&J/MERCK say, because of "unique and complex labeling messages which may not be formatted to the exact intent of CFR [the Code of Federal Regulations]," the consumer products joint venture stated in Sept. 30 comments to FDA on its Feb. 27 proposed revisions to OTC drug labeling. The company believes FDA "intends to recognize and waive those cases where the approved labeling need not necessarily be in complete conformance with the final rule as long as the specific label has undergone FDA review and approval," J&J/Merck writes, asking FDA to clarify the status of NDAed over-the-counter drugs in the final rule.
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS087675

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