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 Digs Deeper On “New Paradigm” To Expand Rx Switches

This article was originally published in The Tan Sheet

Executive Summary

The questions FDA poses for a March 22-23 hearing indicate the agency is delving into greater detail than in its previous discussions of alternative routes to access pharmaceutical treatments. FDA says decisions would be made case by case, but refers to treating conditions including high cholesterol, high blood pressure, migraines and asthma.

You may also be interested in...



US Appropriators Question FDA’s OTC Switch Process Overhaul, Homeopathic Market Oversight

Appropriations Committee’s report with Agriculture, Rural Development, FDA and Related Agencies FY2021 budget bill also reiterated concern about adding acetaminophen dosing information for children to OTC monograph. But its mentions of FDA initiative to expand ingredients available OTC and homeopathic market oversight were firsts.

Room For Innovative Switches Could Lurk In Existing FDA Framework

When firms suggest submitting switch NDAs for “something that would be worth engaging on, we’re not going to tell you no,” says FDA nonprescription drug program chief Theresa Michele.

Room For Innovative Switches Could Lurk In Existing FDA Framework

When firms suggest submitting switch NDAs for “something that would be worth engaging on, we’re not going to tell you no,” says FDA nonprescription drug program chief Theresa Michele.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS105597

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