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

US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them?

Executive Summary

FDA reaches final stages of reorganization that will better distribute an ever-increasing review workload; recent high-level departures will make filling even more management slots difficult.

You may also be interested in...



Ex-US FDA Director John Jenkins Sketches Regulatory Path For Esperion's Bempedoic Acid

Imbalance in deaths in study of novel cholesterol drug has been a concern, but Esperion made the case for safety during a July 10 investor day, which featured presentations by ex-FDA director John Jenkins and Cleveland Clinic cardiologist Steve Nissen.

One Lesson Of The OND Reorg: It Is Hard To Classify Diseases

One goal of proposed overhaul of US FDA’s Office of New Drugs is creating more logical alignment of related diseases within divisions and offices. That is easier said than done.

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).

Related Content

Topics

UsernamePublicRestriction

Register

PS123019

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