Woodcock Defends Speed Of FDA Reviews, Cites 20 Approvals In First Half Of 2011
This article was originally published in The Pink Sheet Daily
Executive Summary
As House begins hearings on PDUFA V, industry and venture capitalists say agency policies pre-NDA submission slow drug development.
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FDA estimates that the number of fee-paying applications will continue to decline, meaning the user fee itself will increase more than 19% to $1.842 million for applications requiring clinical data.