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

FDA 2016 User Fees Hold Steady For Brands, But Are Up – And Down – For Generics

Executive Summary

PDUFA, BsUFA increase moderately, while GDUFA facility fees fall for the first time.

You may also be interested in...



Will PDUFA VI Fee Structure Changes Slow Revenue Growth?

User fee revenue expected to break $1bn threshold by FY 2020, but growth looks to be slower than last few years.

US FDA Raises Problems With EU Data Protection Reg, But Are They Among Those Misunderstanding It?

An FDA blog post says some inspections have been hindered and application assessments soon could be delayed by the EU General Data Protection Regulation (GDPR), but experts argue the law includes directions to allow data sharing and remain compliant.

Pink Sheet Podcast: Monkeypox Vaccine EUA, Drug Pricing Bill Fallout, US FDA’s IT Upgrade

Pink Sheet reporters and editor discuss the new monkeypox vaccine EUA, the potential impact of drug pricing legislation, and how things may have been different if the FDA already had a desired technology upgrade.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS057042

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