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

Unapproved Uses Bill May Eventually Pass, But Would Likely Need Additional Safeguards

Executive Summary

Off-label communication amendments tabled at House markup of user fee legislation after Democrats object; the two sides agreed to discuss the issue further down the road.

You may also be interested in...



Off-Label Communications: Legislative Reform Efforts Struggle, But Continue

At hearing, House Energy & Commerce Committee leadership supports legislation to provide clarity and more latitude in off-label communications at hearing but Democrats oppose broad change.

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.

Generic Drug Roadblock: 74 Brands Subject To REMS, Other Restrictions

Report sponsored by Association for Accessible Medicines in US says drugs with restricted distribution programs had total sales of $22.7bn in 2016; seven drugs had sales topping $1bn.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS120819

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