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 Aims To “NSURE” Clarity About New Paradigm For OTC Switches

This article was originally published in The Tan Sheet

Executive Summary

FDA official Rikin Mehta assures stakeholders that the proposed new paradigm for Rx-to-OTC switches would not create a third class of drugs, give pharmacists prescribing power or eliminate the need for consumers to visit doctors.

You may also be interested in...



A New OTC Switch Pathway In US At Last: Acronym Isn’t The Only Thing That’s Changed

FDA proposes a novel pathway to permit OTC drugs to be marketed with additional controls to assure appropriate use, more than a decade after floating the idea. The pathway has a new name (“ACNU” not “NSURE”) and very different commercial dynamics.

A New OTC Pathway At Last: The Acronym Isn’t The Only Thing That’s Changed

The US FDA is proposing a novel pathway to permit OTC drugs to be marketed with some additional controls to assure appropriate use, more than a decade after floating the idea. The pathway has a new name (“ACNU” not “NSURE”) and very different commercial dynamics.

After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers ‘Novel Switch’ Pathway

Publication of "ACNU" proposed rule wasn’t reached in a straight line and featured coining another term with a more of a regulatory sound, “NSURE.” The proposed rule also detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS106061

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