Equivalence of Complex Products; Public Workshop; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing.'' The purpose of the workshop is to share FDA's current experiences on the evaluation and characterization of critical quality attributes for complex drug substances (e.g. polymeric and naturally derived substances and peptides) and formulations (e.g. liposomes, emulsions, suspensions, and polymeric inserts); discuss current and future innovative approaches for the development and regulatory review of equivalent complex drug products; obtain input from various stakeholders on how to conduct and assess critical quality attribute measurements to demonstrate equivalence of complex drug products; and request comments on these topics.