FDA Announces 3 Upcoming Generic Drug Workshops

FDA has announced three upcoming generic drug development workshops. On 10/2-3, “Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review” will discuss current and emerging scientific approaches and applications for conducting quantitative modeling and simulations in generic drug development, especially for complex and locally acting products. The agency intends to use the information gained through the workshop to support product-specific guidance development, improve pre-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.

On 10/6, a workshop on “Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing” is intended to engage stakeholders in a discussion about the use of in vitro testing to demonstrate bioequivalence of complex generic drug products. And on 10/20, a workshop is planned on “Overcoming Barriers to Product Development, and Commercialization of Affordable, High Quality, Generic Topical Dermatological Drug Products” to provide a platform for discussing current barriers in the development of topical dermatological generic drug products.