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

Xtampza ER Warnings Can't Be Hidden Behind Table And Chairs, US FDA Tells Collegium

Executive Summary

OPDP's first enforcement letter of 2018 is notable because it comes much earlier than 2017's first, cites an opioid, and signals that the US FDA is monitoring medical meetings. 

You may also be interested in...



Collegium, BioDelivery To Combine Pain Portfolios In Proposed Merger

Collegium has offered a 54% share premium to acquire competitor BioDelivery, in an offer approved by both firm’s boards. The $604m price tag would double the size of Collegium’s product portfolio.

US FDA Actions On Rx Drug Promos Covered New Territory Last Year

Office of Prescription Drug Promotion issued just six letters citing companies for improper drug promotion in 2020, including the placement of safety information in an email and making unfounded COVID-19 claims. New research projects focus on celebrity endorsements, medical conference materials.

How Should US FDA Navigate Thorny First Amendment Conundrums: Former Chief Counsels Offer Advice

Daniel Troy suggests FDA increase its investment in science of consumer understanding, while Richard Cooper recommends the "bully pulpit" approach to get industry's attention. A panel of former chief counsels stressed that the agency cannot continue to ignore First Amendment free speech issues.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS122566

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