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

FDA's Ongoing User Fee System Upgrade Limits Payment Options

This article was originally published in The Pink Sheet Daily

Executive Summary

But it comes at a time when there is traditionally a lull in filings of generic drug applications.

You may also be interested in...



GDUFA II: Inspection Information Takes Center Stage

Sponsors say transparency is important as generic drug user fee negotiations move to inspection policy.

PDUFA Negotiations Begin With FDA Seeking Review System Reform

Fee structure changes and process enhancements floated during opening session between industry and agency.

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Topics

UsernamePublicRestriction

Register

OM006051

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