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


FDA’s Drug Review Challenge For 2013: Managing Sponsor Expectations

This article was originally published in RPM Report

Executive Summary

The first late-cycle meetings under FDA’s new drug review process are scheduled to start in February, and the agency is scrambling to manage expectations. What agency officials don’t want: a contentious fight over approvability, followed by a flood of new submissions and appeals. Industry’s response: Good luck with that.


Related Content

FDA’s First “Program” Reviews: Fast Approvals, But Still Some Surprises
PDUFA V and Investor Communications
PDUFA V and Investor Communications
FDA’s Very Big Year: Drug Approvals Approach Record Levels
Time for Transparency: PDUFA V’s Big “Experiment”
An Emerging Approval Trend At FDA: More First-Time Sponsors
FDA's Next-Generation Review Process: Avoiding the "Crisis Mentality"


Related Companies




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