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Geschäft · 10.8.20201 Min. Lesezeit
Drug-Drug Interaction Assessment for Therapeutic Proteins; Draft Guidance for Industry; Availability
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Zusammenfassung
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Drug-Drug Interaction Assessment for Therapeutic Proteins." The purpose of this guidance is to provide a systematic, risk-based approach to help sponsors of investigational new drug applications (INDs) and applicants of biologic license applications (BLAs) determine the need for drug- drug interaction (DDI) studies for a therapeutic protein (TP).
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →