HBW Insight 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


FDA Urged To Change OTC Monograph System, But Not In Midstream

This article was originally published in The Tan Sheet

Executive Summary

“Moving away from the monograph system when we are so close to the end” would “risk setting back the OTC drug review many years or even decades,” CHPA head Scott Melville says at an FDA public hearing. Other stakeholder s explain how the monograph system has failed industry and consumers.

You may also be interested in...

Firms Consult FDA, Add “Do Not Use” For Under 4 To Pediatric Cold Products

Over-the-counter pediatric cough/cold products relabeled "do not use" for children under 4 will reach shelves in the next few weeks in a voluntary program manufacturers coordinated with FDA

FDA Floats Eliminating Multi-Ingredient Pediatric Cold Products

FDA suggests the drug industry consider making pediatric cough/cold formulations available only as single-ingredient products, according to an agency report

FDA Review Of Children’s Cough/Cold OTCs Has Broader Implications

FDA's review of children's over-the-counter cough/cold products will address the broader issue of whether extrapolating pediatric doses from adult dosing data is appropriate


Latest News
See All



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