FDA Publishes FY 2020 GDUFA Science and Research Report On March 17, 2021, the U.S. Food and Drug Administration published the Fiscal Year (FY) 2020 Generic Drug User Fee Amendments (GDUFA) Science and Research Report. This report elaborates on the FY 2020 results of FDA's Science and Research program for generic drug products, which uses GDUFA funds to conduct research activities to aid in the investigation and development of generic drug products. The GDUFA Science and Research program supports the development of innovative methodologies and efficient tools to help establish drug equivalence standards and support the development of, and access to, safe, effective, and high-quality generic drug products for the American public. The report provides detailed FY 2020 updates for 13 topic areas of focus for the GDUFA Science and Research program. In each topic area, results from existing research supported FDA's regulatory decision making through the development of general and Product-Specific Guidances (PSGs), pre-Abbreviated New Drug Application (ANDA) interactions, and controlled correspondence communications with industry prior to the filing of an ANDA submission, and the timely assessment and approval of ANDAs. In FY 2020, the GDUFA Science and Research program also implemented the FY 2020 GDUFA Science and Research Priorities, through the award of 11 new research contracts and 5 grants for innovative research projects on generic drug products. FDA thanks all of its collaborators who contributed greatly to GDUFA Science and Research efforts in FY 2020 and looks forward to the future scientific achievements that will help enhance patient access to generic drugs. The report can be viewed in its entirety at: https://www.fda.gov/drugs/generic-drugs/fy2020-gdufa-science-and-research-report. | 
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