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  1. Development & Approval Process | Drugs

FINANCIAL TRANSPARENCY AND EFFICIENCY

FDA is committed to ensuring user fee resources are administered, allocated, and reported in an efficient and transparent manner. Under PDUFA VI, BsUFA II, and GDUFA II, FDA committed to conducting activities to evaluate the financial administration of these user fee programs to help identify areas to enhance efficiency. FDA also committed to conduct activities to enhance transparency of PDUFA, BsUFA, and GDUFA program resources. These commitments included contracting with an independent third part to conduct an evaluation of PDUFA, BsUFA, and GDUFA program resource management during FY 2018, publishing five-year financial plans for these user fee programs, and convening a public meeting during the third quarter of each fiscal year (starting in FY 2019) to discuss topics related to program resource and financial management.

PDUFA, BsUFA, and GDUFA Five-Year Financial Plans

Meeting: Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments, June 7, 2019

Fiscal Year 2018 Financial Management Evaluation for Human Drug User Fees Assessment Report