Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023

Affiliations

• ¹ Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. Eleftheria.Tsakalozou@fda.hhs.gov.
• ² Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
• ³ Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁴ Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland, USA.
• ⁵ Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA.