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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. He also specifically mentioned rare diseases here , in addition to his example of late-stage illnesses.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. That leaves us to speculate what the implications of this Assessment will be.