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Commissioner Makary Charts a New Course for FDA at FDLI Annual Conference

FDA Law

Livornese Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institutes Annual Conference , continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. Claud & Deborah L.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. Just like it was over a decade ago in Pliva v.