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

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

Executive Summary

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.

You may also be interested in...



US FDA Drug Office Reform: 'Everything' Is On The Table

Deputy Office of New Drugs director says IND evaluation and post-market surveillance could be part of restructuring effort along with changes to application review.

Gottlieb Promotes 'Team' Work For Product Reviews

US FDA Commissioner intends to change agency's siloed structure and move reviewers into teams that will follow products pre- and post-market.

FDA's Oncology Center Of Excellence On Equal Terms With CDER In New Org Chart

While OCE has a lofty status, it has yet to gain a large cadre of staff.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS120263

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