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Tracking Troubled NDAs: New FDA Regs Mean Less Clarity for Investors

This article was originally published in RPM Report

Executive Summary

After an 11-year process, FDA is doing away with "approvable" and "not approvable" letters. . The new name ("complete response") gets rid of the negative connotations of "not approvable". But it is likely to create more confusion-and less transparency--for investors and the public.

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FDA Opens Up: Can Industry Live With Greater Transparency?

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FDA Opens Up: Can Industry Live With Greater Transparency?

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