Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
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

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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