Friday, October 19, 2018 5:58:53 PM
Cost Breakdown For Full NDA Drug Development
A 505(B)(2) can take only 1 to 3 years for approval, and when a clinical trial is needed (not always), they often just need a Phase III trial (no phase I and II). The opportunity cost is a small fraction of a 11 year approval for an NDA. The drug development R&D is also a small fraction. While the article below is concerning distressed generics, I believe it is applicable.
505(B2) Drug Approval Pathway Comparison to NDA
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