Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

PDUFA Collections Exceeded Target In FY 2021, While GDUFA Fell Short

Executive Summary

The US FDA reports that the prescription drug user fee program met 27 of its 29 commitments by the end of FY 2021 and the biosimilar user fee program is on track to meet 16 of 27 of its performance enhancement goals.

You may also be interested in...



User Fee Bill Clears Senate Committee With Importation, Orphan Drug Amendments

Highlighting the much-less-bipartisan atmosphere than the House, ranking member Burr votes against the package; US FDA’s advice to generic applicants could be contentious issue in reconciling the legislation between the two chambers.

Continuous Pharmaceutical Manufacturing Bill Hitches A Ride With US FDA User Fee Legislation

US legislation could advance new manufacturing platforms for drugs and biologics with academic R&D and workforce development and in turn spur domestic growth.

US FDA Accelerated Approval Council Required Under Senate User Fee Bill

Intra-agency group would be tasked with ensuring consistent use of the expedited pathway across the FDA, with duties potentially including development of best practices, product review team training, and advising on withdrawals, according to the Senate's bipartisan user fee legislation.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS146288

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