FDA and Center for Research on Complex Generics Co-Hosted Workshop:  Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products  - 11/30/2021 - 11/30/2021

This workshop engages experts in the field of modeling& simulation in the generic and new drug industries, academia,& relevant stakeholders to explore, identify& recommend best practices for the development and assessment of model integrated approaches for BE assessment of LAI drug products.

Source: FDA Center for Drug Evaluation and Research - What's New - October 21, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news