Tag Archives: 505b2

CDER Exclusivity Board: Can 3-Year Exclusivity Applied to a Prodrug Block 505(b)(2) NDA Approval for the Active Metabolite?

By Kurt R. Karst — This is the second post in a series of posts dedicated to delving into and discussing various issues that arise with both 5-year New Chemical Entity (“NCE”) exclusivity and 3-year new clinical investigation exclusivity based … Continue reading

Posted in Products Liability | Tagged , , , , , , , , , , | Leave a comment