Leveraging Quantitative Methods and Modeling To Modernize Generic Drug Development and Review; Public Workshop; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review.'' The purpose of the public workshop is to engage stakeholders in a discussion of current and emerging scientific approaches and applications for the conduct of quantitative modeling and simulations in generic drug development, especially for complex and locally acting products, and to gain input regarding opportunities and knowledge gaps related to the use of quantitative modeling and simulation to inform regulatory decision making through the product lifecycle. FDA will use the information gained through the workshop to support product-specific guidance development, improve pre-abbreviated new drug applications (ANDA) interactions with applicants, increase the quality and efficiency of regulatory reviews, and identify a next generation modeling and simulation toolset for complex and locally acting products.