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

Battle Over US FDA’s ‘Intended Use’ Rule Continues

Executive Summary

PhRMA and Pfizer attorneys criticize the rule’s broad evidence standard, lack of safe harbors, and disregard of the First Amendment. Opposition to the rule is expected to continue to play out in lawsuits.

You may also be interested in...



Off-Label Use Final Rule: US FDA Declines To Focus Solely On Promotional Claims

In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.

Rx Data Mining Opponents Will Need New Pitch After Supreme Court Strikes Down Vermont Law

The court affirms the Second Circuit's ruling that a Vermont statute prohibiting drug companies from using Rx data to market to doctors imposes an impermissible restriction on free speech.

Social Media Data Gains Prominence In Patient-Focused Drug Development

FDA guidances have provided ‘major step forward’ for use of social media data, Roche researcher notes. Agency staffer offers checklist for collecting patient experience data in this realm.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS145136

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