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

 
• By Kate Rawson

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.

Big change can come in small packages.

That pretty much sums up how Food & Drug Administration officials feel about a change in the type of companies that are submitting new drug and biologic applications to the...

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