Presenters and a panel discuss leveraging model integrated evidence for long-acting injectables (LAIs) to reduce regulatory barriers. Presentation titles include, “Model Integrated Methods for Generic LAI Product Development and Regulatory Assessment: Current Status and Future Research Directions” and “How Can Model Integrated Evidence Accelerate LAI Generic Availability?”
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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