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

US FDA Tiptoes Further Into Off-Label Use Discussions With CURE ID App

Executive Summary

App allows clinicians to discuss off-label treatments, but information is intended to be hypothesis-generating, not for regulatory use.

You may also be interested in...



REMS Integration Into Electronic Health Records To Be Tested By US FDA In Software Pilot

The prototype pulls information from the electronic record to fill out enrollment and other forms, but stakeholders say it must work for most, if not all, REMS drugs in order to be widely used.

Coccidioidomycosis Outlook Highlights The Limits Of Regulatory Incentives

The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.

CURE ID Expands Into COVID-19; Oncology And Rare Diseases Are Next

After slow start early in SARS-CoV-2 pandemic, CURE ID now has more than 150 case reports of drugs to treat the coronavirus.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141334

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