FDA Misses User Fee Goals As Resources Tighten For Reviews, SPAs
This article was originally published in The Tan Sheet
Executive Summary
With the ink of the reauthorized Prescription Drug User Fee Act still drying, FDA is signaling that it may be some time before the agency will consistently meet the performance goals of its user fee program
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After an almost two-year hiatus from strict adherence to Prescription Drugs User Fee Act review timeframes, Office of New Drugs Director John Jenkins has told review staff that, once again, they should strive to meet the user fee deadlines
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After an almost two-year hiatus from strict adherence to Prescription Drugs User Fee Act review timeframes, Office of New Drugs Director John Jenkins has told review staff that, once again, they should strive to meet the user fee deadlines