An FDA reform agenda: What would Commissioner Scott Gottlieb do in his first six months?
An accelerated approval pathway for complex generics, embracing killer apps, publishing CRLs and a swift kick in the leadership at the FDA all figure prominently.
President Trump has made it clear that he’s looking for a revolution at the FDA, which in turn has raised fears that he’ll appoint a revolutionary deregulator as commissioner who will blow up a well established gold standard on drug approvals.
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