Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

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.

You may also be interested in...



Separating Gene Therapy ‘Wheat’ From ‘Chaff’: CBER Facilitators Could Help Inexperienced Sponsors

Surge of interest prompts US FDA to consider how to adjust feedback, including potentially creating a separate team to answer more basic questions.

FDA Sponsor Liaison Program Is Not Being Used: Are Small Biotechs Missing An Opportunity? Or Partnering More?

FDA has noticed a perplexing – and somewhat vexing – trend among smaller, less experienced pharma companies: They are not taking full advantage of a new liaison program designed to increase sponsor/FDA communication – even when they hit roadblocks during the drug review process. FDA officials have heralded the program as one of the most important under PDUFA V. So why aren’t companies using it?

GAIN Begins (Part 1): FDA Completes Turnaround On Antibiotic R&D

In less than two years, FDA has moved from requiring unrealistic approval standards for antibiotics to exploring innovative ways to shorten the pathway for the most-needed drugs. And, surprise: Congress is on board too. After 15 years, there is finally real momentum on antibiotic drug policy. But is it all enough to get companies back in the game?

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1125120

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

Cancel