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Presenter describes internal alignment: four elements and the 'single MDD' concept
Summary
The presenter outlined four alignment elements — standardized approaches, a single MDD concept, knowledge management, and quality control — and said the single-MDD set at original NDA approval should be propagated to referencing generics and maintained through the product lifecycle.
The Presenter described an internal effort to align MDD determination across disciplines and product life cycles. He identified four key elements: standardized approaches and principles, a single MDD concept, active knowledge management, and quality control for documented MDDs.
On the "single MDD" concept, the Presenter said the goal "is to determine the MDD at the time of original NDA approval and then to use that MDD throughout the drug's life cycle," noting that updates to the reference drug's MDD (for example via an efficacy supplement) should be propagated to referencing ANDAs and generics so that reference and generic products are evaluated consistently.
