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

PDUFA Talks: FDA Floats “Information Sharing” Pause In New Review Model

Executive Summary

FDA’s new proposed review model would break the process into four distinct phases and eliminate some extensions of the review deadline, yet the actual review cycle still likely would be lengthened.

You may also be interested in...



FDA Could Answer "Clarifying" Questions, But Only For Firms Without Approved Product

The drug industry is not only worried about vulnerable patients, it's worried about vulnerable companies.

FDA May Require NDA Pre-Filing Meeting Under PDUFA V Review Model; Pilot Launching Soon

The new application review process being negotiated as part of the PDUFA V reauthorization is nearing the pilot stage and could require sponsors to have the bulk of their information ready before submission.

FDA Could Answer "Clarifying" Questions, But Only For Firms Without Approved Product

The drug industry is not only worried about vulnerable patients, it's worried about vulnerable companies.

Related Content

Topics

UsernamePublicRestriction

Register

OM007016

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