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de novo

Optiscan receives FDA feedback to pursue de novo pathway for oral imaging

Digital microscopic imaging company Optiscan (ASX: OIL) has gotten feedback from the US Food and Drug Administration (FDA) in relation…

3 years ago

Q&A: Paradigm to answer FDA questions to achieve Investigational New Drug status

The commercialisation of osteoarthritis treatment ZILOSULĀ® has hit a hiccup in the United States with the US Food and Drug…

4 years ago