Model-Integrated Evidence (MIE) Industry Meeting Pilot Between FDA and Generic Drug Applicants

Prospective generic drug applicants and generic drug applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) establishment in their abbreviated new drug applications (ANDAs).
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news