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...
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The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
