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

UsernamePublicRestriction

For Successful OTC Switch Proposals, A Good Offense Defends Against Doubters

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail their switch, s consultant advises. Some switches fail because firms target regulatory approval and do little on marketplace performance.

You may also be interested in...



OTC Switches Face Tougher FDA Evaluations, Less Predictable Process

OTC switch sponsors bear more responsibility than in previous years to convince FDA a product would be safely used and has a strong risk/benefit profile, say Pinney Associates consultants. FDA currently is more conservative on risk/benefit decisions and the advisory committee process isn't productive, they say.

Chronic Conditions Data Emphasize Need For Additional, Innovative OTCs

An NIH-funded study shows 92% of older consumers have chronic conditions, the primary target of FDA’s Nonprescription Safe Use Regulatory Expansion initiative to facilitate more Rx-to-OTC switches. The agency also extends the comment period for its initiative on making more ingredients available through the OTC monograph process.

GSK's Quesnelle Brings Expertise In Switch To Consulting Arena

Through 30 years working in the pharmaceutical industry, George Quesnelle became a leading expert on the Rx-to-OTC switch process. At GlaxoSmithKline, he led the charge in switching Nicorette and NicoDerm CQ smoking cessation products, as well as alli for weight loss.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

RS122619

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