In Vivo 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


PDUFA Extension Adds More than Funding

Executive Summary

The expiring Prescription Drug User Fee Act (PDUFA) has been reauthorized and expanded. For the first time, the bill provides a mechanism for risk management planning. The new PDUFA also requires FDA to turn to independent consultants to help resolve disputes over Phase III trial design. At a time when managerial issues at the FDA seem to have raised the level of uncertainty, the new PDUFA rules could prove a welcome measure of predictability.

Related Content


Related Companies




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