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Latest From Michael McCaughan
FDA’s disclosure of data “manipulation” in the application for the SMA gene therapy Zolgensma prompted two immediate inquiries from the US Senate – with very different focuses and potential outcomes.
Robert Temple, the FDA's voice of institutional memory, believes drug regulation has quietly entered a third era: the “Age of Individualization.” Unlike the prior eras of safety and efficacy, there is no milestone legislation to set the ground rules.
Primary sponsors of the 21st Century Cures Act are trying to get the band back together. Is there hope to recapture a bipartisan, pro-innovation spirit in the current US Congress?
US FDA approved expanded label for male breast cancer based on a supplement that included only non-traditional data sets. But agency is making clear that the “substantial” evidence for efficacy still came from the traditional pivotal trials – in women.
Upcoming transition in HHS drug pricing policy staff reinforces the Trump Administration's shift away from the 2018 "Blueprint” and towards engaging with bipartisan Congressional legislation – and spotlighting executive action as coming from the White House in the context of the upcoming Presidential campaign.
US FDA's advisory committee review of Gilead’s Descovy for pre-exposure prophylaxis of HIV wasn’t exactly free of controversy. But the meeting sure went more smoothly than the first PrEP review seven years ago.