Public Meeting on Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act,
Date: June 7, 2019 Time: 9:00 a.m. to 12:00 p.m. Location: FDA White Oak Campus 10903 New Hampshire Ave. Building 31 Conference Center, The Great Room (Rm 1503A) Silver Spring, MD 20993 (Enter at Building 1 to clear security) Description The Food and Drug Administration (FDA) is hosting a public meeting and an opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” This public meeting is intended to meet performance commitments included in PDUFA VI, BsUFA II, and GDUFA II. These user fee programs were reauthorized as part of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) signed by the President on August 18, 2017. The complete set of performance goals for each program are available at: PDUFA VI program: https://www.fda.gov/downloads/ForIndustry/UserFees/ PrescriptionDrugUserFee/UCM511438.pdf BsUFA II program: https://www.fda.gov/downloads/forindustry/userfees/ biosimilaruserfeeactbsufa/ucm521121.pdf GDUFA II program: https://www.fda.gov/downloads/forindustry/userfees/ genericdruguserfees/ucm525234.pdf Each of these user fee programs included a set of commitments related to financial management. These included commitments to publish a 5-year financial plan that should be updated annually, develop resource capacity planning capability, modernize time reporting practices, and have a third-party evaluation of resource management practices for these user fee programs. This meeting is meant to satisfy FDA's commitment to host an annual public meeting in the third quarter of each fiscal year beginning in FY 2019 (II.B.3 of PDUFA VI (p. 38), IV.B.3 of BsUFA II (p.28) and VI.B.4 of GDUFA II (p.22)). The Federal Register Notice announcing this meeting can be found here: For more information about travelling to FDA's White Oak Campus, see here: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241748.htm.
10903 New Hampshire Ave. , Building 31, Room 1503 (Great Room)
Silver Spring, MD
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