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


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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

You may also be interested in...

OTC Switch “Blueprint” Could Help Regulatory Navigation – Researchers

Rx-to-OTC switch questions that FDA asked advisory committees over the past 10 years can help guide future sponsors to success, says the lead researcher in an analysis of the agency’s switch actions.

FDA Advisors Say Greater Insight Needed On Self-Selection Of OTC Statins

More information from "real world" experiences on how consumers make OTC selections may be needed to pull off a successful Rx-to-OTC switch of a statin

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

Related Content


Related Companies

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