Abbreviated New Drug Application (ANDA) and Pre-ANDA Experience with Orally Inhaled Drug Product (OIDP) Modeling

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Author/sWalenga, Ross
Date:09/30/2021
Meeting Name:FDA and the Center for Research on Complex Generics (CRCG) Workshop: Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches
State:
City:Virtual
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