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 VII: FDA, Industry Agree To Set Minimum Carryover Balance Levels

Executive Summary

The minimum total will increase from eight weeks of operating expenses in FY 2023 to 10 weeks by FY 2025.

You may also be interested in...



PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing

The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.

As Pandemic Delays Reduce PDUFA Revenues, US FDA Slows Fee-Related Spending

Agency cites “unexpected and large drop in collections” in slashing user-fee-setting contract.

PDUFA VII Could Expand US Real-Time Review Beyond Oncology

A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.

Related Content

Topics

UsernamePublicRestriction

Register

PS144062

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