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 V: FDA Offers Mid-Cycle Review Talks, But Industry Wants Them Later

Executive Summary

As negotiations about the next user fee cycle continue, FDA is offering an opportunity for sponsors to formally discuss an application's progress with reviewers, although it appears the new proposed meeting would come too early in the process for industry’s satisfaction.

You may also be interested in...



FDA Floats 15-Month Review Timeline For PDUFA V; Firms Mull Tradeoff On Speed Vs. Certainty

Fifteen months could become the expected review time for new molecular entity and novel biologics license applications, based on a proposed new review model.

FDA Floats 15-Month Review Timeline For PDUFA V; Firms Mull Tradeoff On Speed Vs. Certainty

Fifteen months could become the expected review time for new molecular entity and novel biologics license applications, based on a proposed new review model.

Biosimilars: FDA Casts Wide Net For Creation Of User Fees

Agency seeks "consultation meetings" with patient, consumer, professional and academic groups as it develops congressionally-mandated report on the nascent approval pathway.

Related Content

Topics

UsernamePublicRestriction

Register

SC142962

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