Eleftheria Tsakalozou, PhD: No financial relationships to disclose
This talk will provide an overview of key operational aspects of MMFs under Type V DMF submissions to the FDA. Notably, Dr. Fang will highlight the incentives and benefits for the generic drug industry in incorporating MMF submissions into their regulatory submissions leading to a more streamlined process that improves regulatory assessment consistency and overall acceptability of M&S approaches for generic product development and approval.
