Review of Prescription Drug User Fees

The Prescription Drug User Fee Act of 1992, Pub. L. 102-571, authorized Food and Drug Administration to collect fees from pharmaceutical and biotechnology companies seeking Food and Drug Administration approval of certain human drug and biological products to expedite the review of human drug applications. Food and Drug Administration is expected to use the user fees it collects under the Act to meet its goals for the timely review of human drug applications. We will review Food and Drug Administration policies and procedures and financial records related to prescription drug user fees to determine whether Food and Drug Administration appropriately expended user-fee collections and accurately computed user-fee rates.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
October 2017	Food and Drug Administration	Review of Prescription Drug User Fees	Office of Audit Services	W-00-16-50003	2018