Pink Sheet is part of the Informa Intelligence Division 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


Not Another FDAAA – Observers Expect Fewer FDA Reforms In PDUFA V

Executive Summary

Congress is not expected to pile as many new responsibilities on FDA in the upcoming Prescription Drug User Fee Act reauthorization as in 2007’s FDA Amendments Act.

Related Content

Lilly's Field Of Dreams: "Campaign For Modern Medicines" Wants A Clean PDUFA
Drug Shortages Are A Matter Of Time As Bill Sponsors Work To Show Warnings Will Help
Women's Right To Choose Avastin Debated During House PDUFA Hearing
What’s In A PDUFA Reauthorization? Maybe These Issues…
What’s In A PDUFA Reauthorization? Maybe These Issues…
Woodcock Defends Speed Of FDA Reviews, Cites 20 Approvals In First Half Of 2011
BIO’s "Big Ideas" For FDA Reform Are Too Big For PDUFA
FDA Looks To Capitol Hill For New Authority For Globalization Plan
CMS' 2012 Budget Looks To Biosimilars, Ban On Brand/Generic Deals To Offset Costs
REMS 2.0: FDA Refining New Drug Safety Tools





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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