PDUFA VI: FDA Wary Of Industry Proposals With More Metrics
This article was originally published in The Tan Sheet
Review system proposals could overburden staff, FDA says; formal meeting goals already on tap for changes.
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The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.
Hope is to quickly reject obviously inadequate designation requests, but few meet criteria for dismissal so far.
Fee structure changes and process enhancements floated during opening session between industry and agency.