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


An Emerging Approval Trend At FDA: More First-Time Sponsors

This article was originally published in RPM Report

Executive Summary

There is a surprising trend in the list of FDA approvals in 2011: an increase in the number of small biopharma companies opting to forgo Big Pharma partnerships and submit new product applications on their own. Here’s how these “emerging sponsors” are changing the way FDA does business—for big and small companies alike.


Related Content

FDA Sponsor Liaison Program Is Not Being Used: Are Small Biotechs Missing An Opportunity? Or Partnering More?
GAIN Begins (Part 1): FDA Completes Turnaround On Antibiotic R&D
FDA’s Drug Review Challenge For 2013: Managing Sponsor Expectations
Small Companies Turning To CDER Ombudsman For Help With Drug Approvals
“Feasibility” Counts at FDA: Different Approach in Antibiotics
Conflict Over Conflicts: FDA Advisory Committee Rules May Be Ripe For Change
Time for Transparency: PDUFA V’s Big “Experiment”
FDA’s Banner Year for Drug Approvals: Time to Change the Focus
Getting the Bugs Out of Antibiotic R&D: Commercial Implications of a Higher Regulatory Hurdle


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