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Geschäft · 5.10.20011 Min. Lesezeit
Guidance for Industry on Cancer Drug and Biological Products-Clinical Data in Marketing Applications; Availability
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Cancer Drug and Biological Products--Clinical Data in Marketing Applications." This guidance provides recommendations for sponsors designing clinical trials to demonstrate the safety and efficacy of cancer treatments on the collection of data that can be submitted to support marketing claims in new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →