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

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

This article was originally published in The Tan Sheet

Executive Summary

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

You may also be interested in...



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

“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.

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

“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.

Risk/Benefit Value Tool Could Trim Guesswork From OTC Switch Attempts

The World Self Medication Industry and related trade groups created a value-tree framework with predefined major risk and benefit domains to help firms and regulators identify the opportunities and challenges a product or switch candidate poses.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS100274

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