Medtech 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

Industry Groups Petition To Block FDA Intended-Use Rule

Executive Summary

Trade groups say FDA’s redefinition of intended use is an overreach and would pose constitutional problems. The agency has yet to respond to a petition asking for the rule to be withdrawn.

You may also be interested in...



US FDA Clarifies ‘Intended Use’ Policy For Approved Products

‘Totality of evidence’ establishes that a manufacturer intends a drug to be used for unapproved conditions, agency says; PhRMA says final rule disregards multiple courts’ protection of free speech.

Vascular Solutions Case (Partially) Points Way Forward For Off-Label Marketing

Attorneys involved with a recent court ruling favoring Vascular Solutions believe the verdict might give manufacturers more latitude to engage in truthful, non-misleading, off-label speech. But caution is necessary.

COVID-19 EUAs To Stay Active After Public Health Emergency Ends

Authorizations in place for diagnostics, personal protective equipment, and other products cleared for emergency use during the pandemic will remain in place until the potential for an outbreak no longer exists or products receive traditional clearances, according to a Federal Register notice issued by HHS this week.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT104558

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