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

How a Rapid and Well-Messaged US FDA Offense Is Driving Spectators to Their Feet and Twitter Accounts

Executive Summary

Consultant examines why FDA seems to be accomplishing so much under FDA Commissioner Gottlieb’s leadership and how this could inform future leadership selections.

You may also be interested in...



US FDA Wants More Examples Of Real-World Data Use

CDER Director Woodcock says for regulatory purposes, using real-world data likely will remain a case-by-case decision.

Drug Importation Can Be Triggered By 'Excessive' Price Increases; Now US FDA Has To Decide What That Means

Did FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar have a change of heart on importation? Or are they being pressured from above?

Gene Therapies Need Long-Term Follow-Up Plan From Outset Or Risk Clinical Hold

Although a sponsor may conclude that a long-term follow-up protocol is not necessary for a gene therapy, FDA may have a different interpretation, and the agency won't let studies start if that's the case, draft gudiance states.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS123729

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