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 Promotes 'Team' Work For Product Reviews

Executive Summary

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

You may also be interested in...



Vocabulary Change: CDER Eliminating 'Review' For NDAs And BLAs

Like ANDA evaluations, US FDA plans to use the word assessment to describe them for NDAs and BLAs.

Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions

Long-planned OND 'modernization' to better match workflow, allow more time with stakeholders includes proposed restructuring that would boost number of offices overseeing review operations (adding four for a total of nine) and drug review divisions (adding 11 for a total of 30).

Clinical Study Disclosures Will Make Drug Reviews More Efficient – Gottlieb

US FDA pilot program linking drug approval documents to sponsors' clinical study reports will improve review efficiency and access to information by medical researchers and drug developers, commissioner says; move also could aid sponsors when it comes to reimbursement decision-making, Foley and Lardner's Rosen predicts.

Related Content

Topics

UsernamePublicRestriction

Register

PS142970

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