FDA Guidance for Industry: Bridging for Drug-Device and Biologic-Device Combination Products
Titel:
FDA Guidance for Industry: Bridging for Drug-Device and Biologic-Device Combination Products
Internet:
Herkunft/Verlag:
FDA
Inhalt:
This guidance provides recommendations to industry and FDA staff on how to approach 19 bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-20 device and biologic-device single entity or copackaged combination products including the 21 following