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

PDUFA Update: FDA Wants To Automatically Extend Complex Application Reviews

Executive Summary

FDA wants industry to agree to a set of reasons that would automatically trigger a longer application review as part of the negotiations on reauthorizing the Prescription Drug User Fee Act.
Advertisement

Related Content

NDA Data Standardization Efforts Emerging Along Public, Private Fronts
NDA Data Standardization Efforts Emerging Along Public, Private Fronts
PDUFA V: FDA Could Offer Non-Binding Advice, If It’s Binding
What’s A "Complete" Application? Clarity From FDA Could Speed Review Times
PDUFA V: FDA Could Offer Non-Binding Advice, If It’s Binding
What’s A "Complete" Application? Clarity From FDA Could Speed Review Times
FDA Floats 15-Month Review Timeline For PDUFA V; Firms Mull Tradeoff On Speed Vs. Certainty
PDUFA Talks: Four-Phase Review Flops; Automatic Extensions Back On Table
PDUFA Talks: FDA Floats “Information Sharing” Pause In New Review Model
REMS Templates Get Nod From FDA, With Nudge From Pharmacists

Topics

Advertisement
UsernamePublicRestriction

Register

PS052677

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