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

User Fee Waivers For Small Businesses Might Get Smaller Under PDUFA V

Executive Summary

FDA wants to tighten its eligibility restrictions for small business waivers of user fees, but industry does not appear interested in changing the rules, even if it would hold down costs for other applicants.

You may also be interested in...



PDUFA Formula Could Better Incorporate Present Economic Conditions

FDA may give up some consistency in its user fee inflation formula, making it more beholden to the short-term whims of the U.S. economy.

PDUFA Formula Could Better Incorporate Present Economic Conditions

FDA may give up some consistency in its user fee inflation formula, making it more beholden to the short-term whims of the U.S. economy.

PDUFA V: FDA Relaxes Pre-Submission Meeting Requirement

Sponsors may have negotiated a four-month reprieve for the required pre-submission meeting in the proposed new application review system expected to be implemented with PDUFA V.

Related Content

Topics

UsernamePublicRestriction

Register

PS053217

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