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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