The US Food and Drug Administration (FDA) is exploring the use of model master files (MMFs) to enable sponsors to use the same modeling approach to support different generic drug development programs, potentially from different sponsors, in lieu of conducting clinical studies, according to officials who spoke at a 3 May workshop.
FDA officials also provided an update on different modeling approaches used in new drug applications and generic drug applications at the workshop, which was sponsored by FDA and the Center for Research on Complex Generics (CRCG)…
