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

Breakthrough Requests: FDA Adds Quick Screen To Pare Workload

This article was originally published in The Pink Sheet Daily

Executive Summary

Hope is to quickly reject obviously inadequate designation requests, but few meet criteria for dismissal so far.

You may also be interested in...



Sponsors, FDA Reviewers To Get More Flexibility Under New User Fee Program

Next iteration of PDUFA will feature new communication plans that allow FDA and sponsors to drop mid-review meetings if desired.

FDA's Breakthrough Bar May Be Set Too Low, Jenkins Says

Office of New Drugs Director recommends that EMA be careful how its sets the bar for its similar PRIME program to ensure it remains meaningful.

Breakthrough Designation Can Be 'Lever' For Manufacturing Evolution, FDA Says

CDER Director Woodcock notes breakthrough program often pushes sponsors to modernize production processes.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS077988

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