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Sharpless Confirms Interest In Being Permanent Commish

Executive Summary

Speaking to an audience in Washington, DC, the acting commissioner of the US FDA said he’d like to be nominated and confirmed to the job permanently. However, given the current political climate that may not happen until after the 2020 presidential election.

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'Full-Speed Ahead,' Says Acting US FDA Chief Sharpless

In his first speech to agency staff, US FDA acting Commissioner Ned Sharpless says the agency will continue working on issues such as the Medical Device Safety Action Plan, the precertification program and the National Evaluation System for health Technology (NEST). He also says he's not approaching the post like a temporary caretaker.

Unfinished Business: LDT Legislation A Top Priority For Departing FDA Chief Gottlieb

In a farewell talk at the Brookings Institution, outgoing US FDA Commissioner Scott Gottlieb said a top unfinished business that he hopes gets done after his April departure is legislation to regulate laboratory developed tests. While FDA had been looking to issue guidance on LDTs, he argues there isn’t sufficient legal authority for the agency to regulate the sector.

NCI Director And Former Dx Start-Up Founder Sharpless Will Helm FDA

After a week of speculation as to who will succeed US FDA Commissioner Scott Gottlieb when he steps down next month, Health and Human Services Secretary Alex Azar announced during a congressional hearing that National Cancer Institute Director Ned Sharpless will step in as acting commissioner. One note of medtech interest in Sharpless' bio: he was a co-founder of a diagnostics company.

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