October User Fee Lineup Includes 7 NMEs; Many Expect “Approvable” Action
Executive Summary
FDA enters the fourth quarter with at least 28 pending applications with October user fee deadlines, including seven new molecular entities and one new biologic
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FDA User Fee Review Staff Hiring To Be Lower Than Projected Under PDUFA III
FDA plans to add 376 additional staff years to the drug review process over the course of PDUFA III, about 75 fewer than initial projections
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