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

FDA's Opioid Regret? Skipping Another Zohydro Meeting, Califf Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency addressed post-marketing concerns raised by advisory committee, Commissioner tells Senate, but should have returned to get panel's blessing.

You may also be interested in...



The Short And Controversial Life Of Zohydro Comes To An End

US FDA’s approval of the opioid over resounding opposition of an advisory committee has haunted the agency, and it has imperiled both of Robert Califf’s nominations to be commissioner. The latest company to own Zohydro stopped selling it and FDA withdrew approval of its NDA.

Unasked Questions: The Odd Dynamics Of FDA Commissioner Hearings

Is there anything less satisfying than a confirmation hearing for US FDA commissioner? Robert Califf performed very well during his testimony to return to the post, but no one who follows FDA closely likely learned much they did not already know.

Unasked Questions: The Odd Dynamics Of FDA Commissioner Hearings

Is there anything less satisfying than a confirmation hearing for US FDA commissioner? Robert Califf performed very well during his testimony to return to the post, but no one who follows FDA closely likely learned much they did not already know.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS079232

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