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
You may also be interested in...
FDA Improves Drug Review Timeframes, Aims For Original PDUFA Standard
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
FDA’s Good Review Management Practices To Debut In “Near Future”
The long-awaited good review management practice procedure is ready to be rolled out, according to Center for Drug Evaluation and Research Deputy Director Douglas Throckmorton
When Reagan-Udall Foundation Gets Started, Funding Is First On To-Do List
The FDA Amendments Act created an abundance of oversight functions to organize in the broad new powers it authorized to FDA for ensuring drug safety, but the act also provides the agency with an outside partner - the Reagan-Udall Foundation