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


PDUFA V: Emerging Sponsor Communication Issue Resolved And Expanded

Executive Summary

FDA and industry plan to create more staff to help deal with simple and clarifying questions from emerging and experienced sponsors during the application review process as part of PDUFA V.

Related Content

FDA Emergency Use Power Could Expand Under Bill Moving To House Floor
FDA's "Entrepreneurs-In-Residence" Program Aims To Help Small Companies
FDA Must Codify Flexibility For Rare Diseases, Coté Says As He Moves To NORD
Not Another FDAAA – Observers Expect Fewer FDA Reforms In PDUFA V
BIO’s "Big Ideas" For FDA Reform Are Too Big For PDUFA
Drug Shortage Legislation Gains Momentum With Bipartisan House Bill
Sens. Burr and Coburn Want User Fee Bills That Streamline Regulation
Orphan Drugs Need Easier, Speedier Approval, Not More Exclusivity, CEO Says
PDUFA V Agreement Appears Set Between FDA And Industry
FDA Could Answer "Clarifying" Questions, But Only For Firms Without Approved Product





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