The problem might not be in legislation but implementation. Obviously, FDA has felt uncomfortable reviewing FOB applications in any way that can be considered timely. Either review schedules need to be stipulated by the regulations or FDA needs more specific guidelines.
What was FDA's rationale for the delay for omnitrope which required NVS to sue for approval. I don't claim to be an expert here, just an observer who believes the system is disfunctional.
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