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

US FDA Commissioner Confirmation: Gottlieb To Get Questions On Approval Standards, Ties To Industry

Executive Summary

Top Senate committee Democrat Patty Murray tweeted concerns about Gottlieb's positions on 'gold standard' of FDA approval; Public Citizen's Michael Carome ultimately thinks Gottlieb will be approved.

You may also be interested in...



Gottlieb's Confirmation: Will Industry Ties Remain A Big Deal After The Hearing?

The US FDA commissioner does not generally get involved with day-to-day activities, former FDA chiefs say, but perception of bias could be lasting problem.

Gottlieb's FDA: Specialized Groups Could Create Review Consistency, Speed

US FDA commissioner nominee might employ modular specialists to work with review divisions on issues related to gene therapies, molecularly-targeted drugs, adaptive clinical trial designs, or other complex issues.

Biosimilars: Next User Fee Cycle Will Be Judged On US FDA's Approvals, Rep. Burgess Says

Chair of the House Energy and Commerce Health Subcommittee expects BsUFA II also to be judged on FDA's review process predictability.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS120217

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