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

The Real PDUFA Inflation Rate

Executive Summary

The FDA/Industry agreement for PDUFA VI envisions a relatively modest increase in the amount of user fees paid by brand name companies; the length of the “commitment letter” outlining the agreement, however, expanded dramatically.

You may also be interested in...



PDUFA VII’s Big Commitments: ‘Goal Inflation’ Accelerates

Latest iteration of the Prescription Drug User Fee Act agreement negotiated by US FDA and the pharmaceutical industry continues the trend to ever larger sets of goals and commitments as part of the reauthorization process.

Rare Disease Integration Into FDA Reviews Will Grow Under PDUFA VI

Stakeholders wonder about impact of placing orphan drug program staff "into review teams" as part of next iteration of user fee program.

Did The Congressional Budget Office Just Make Price Negotiation Inevitable?

Not only does the CBO’s new model make the impact of draconian changes look small, it also gives a framework for compromise that could make legislation more likely to pass Congress.

Topics

UsernamePublicRestriction

Register

PS118809

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