An Emerging Approval Trend At FDA: More First-Time Sponsors
This article was originally published in RPM Report
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...
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?
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?