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

Biopharma Wins Reprieve On US FDA 'Intended Use' Rule

Executive Summary

In response to MIWG petition, agency delays by one year implementation of final rule on what activity is considered evidence of a manufacturer's intended use of a product.

You may also be interested in...



Off-Label Communications: Near-Term ‘Seismic Shift’ In FDA Oversight Unlikely

It’s not realistic to expect sudden changes in US agency’s regulation of medical product communications to healthcare providers and payers given the other pressing issues facing new Commissioner Scott Gottlieb, Medical Information Working Group’s Klasmeier says.

‘Intended Use’ Rule: Industry Urges US FDA To Revoke ‘Totality Of Evidence’ Standard

Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.

First Amendment Does Not Block Off-Label Enforcement Actions, FDA Reiterates

Agency memo on manufacturer communications about unapproved uses says new court rulings and studies on off-label uses and adverse reactions support restrictions; whether agency’s new leadership has the same view remains to be seen.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS120252

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