US FDA's Gottlieb Touts 'Seamless' Clinical Trials, Worries About Second-To-Market Products
Commissioner tells House hearing that agency study found troubling drop in innovative competition; clinical trial reform, including encouraging surrogate markers, could speed development of products that may create pricing pressure on brands.
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Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition
In interview with the Pink Sheet, US FDA Commissioner Scott Gottlieb offers a final reflection of his time as commissioner.
CDER Director Woodcock says pricing and approval issues are becoming "conflated" but it is hard to change people's minds when they are "determinedly angry about something."