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

Nasal moisturizers

This article was originally published in The Tan Sheet

Executive Summary

Nasal moisturizers should be removed from FDA's OTC product review and regulated as cosmetics, law firm Kirkpatrick & Lockhart (Washington, D.C.) maintains in comments to FDA. Claims that the products provide moisture for inflamed nasal membranes due to colds "is not indicating a treatment for the cold, or other specific disease, nor is it claiming to mitigate or cure that disease," lawyers assert. The comments were submitted in response to FDA's call for data on unreviewed drug products as part of the OTC safety review (1"The Tan Sheet" Jan. 5, 2004, p. 11)...

You may also be interested in...



FDA Issues Call For Data On Unreviewed OTCs To Complete Drug Review

FDA is requesting information on whether urinary analgesic/antiseptic products are appropriate for self-medication in a call for data on a range of products eligible for the OTC drug review. The notice was published in the Federal Register Dec. 31

Simplified Clinical Trial Transparency Rules To Go Live In The EU In June

A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules. 

Top-Selling Drugs 2023: Pharma’s $60bn COVID-19 Cliff

Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS097096

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