|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FY21 GDUFA Science and Research Outcomes Report Available Today, FDA released its fiscal year (FY21) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. The report details the extent to which GDUFA-funded science and research projects in FY21 supported: - development of generic drug products,
- generation of evidence needed to support efficient review and timely approval of abbreviated new drug applications,
- and evaluation of generic drug equivalence.
The report is part of the enhanced accountability and reporting commitments included in GDUFA II. Metrics from FY21 research outcomes are reported for each of the three categories listed above within summary tables in the report. See previous reports for more details about the research outcomes in each category, including lists of publications, presentations, and posters, links to product-specific guidances, and information about workshops at which scientific advancements and regulatory advice were communicated to the generic drug industry. | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
No comments:
Post a Comment