PDUFA Negotiations Begin With FDA Seeking Review System Reform
This article was originally published in The Pink Sheet Daily
Fee structure changes and process enhancements floated during opening session between industry and agency.
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PDUFA renewal could establish process that allows firms early warnings about Sentinel and other safety data announcements.
But it comes at a time when there is traditionally a lull in filings of generic drug applications.
Review system proposals could overburden staff, FDA says; formal meeting goals already on tap for changes.