Pink Sheet is part of the Business Intelligence Division 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

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

Executive Summary

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

Advertisement

Related Content

PDUFA V 'Program' First-Cycle Approval Rates Significantly Higher For All Applications
FDA Meets ANDA Backlog Goal Early, Still Doesn't Feel Out Of Woods
FDA's Breakthrough Bar May Be Set Too Low, Jenkins Says
Two Out Of Three Ain't Bad: Biosimilar User Fee Talks Completed
PDUFA Negotiations End, Approval Process Ongoing
PDUFA Negotiations: Early Communications, Breakthrough Still On Docket
Breakthrough Requests: FDA Adds Quick Screen To Pare Workload
PDUFA V Reviews Are ‘Best Ever’ For Some Sponsors, Maybe Not FDA
FDA Review “Program” Tweaks May Include Smaller Mid-Cycle Meetings
Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model

Topics

Advertisement
UsernamePublicRestriction

Register

PS118786

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