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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.

Gottlieb at Brookings
Speaking at Brookings Institution, outgoing FDA Commissioner Scott Gottlieb said he hopes LDT legislation is passed within a year • Source: Ferdous Al-Faruque

In what was one of his last public talks as US FDA commissioner, Scott Gottlieb said he’d like to see Congress pass legislation that would allow the agency to regulate laboratory developed tests. He hopes the issue is addressed before the next device user-fee negotiations.

Gottlieb spoke at the Brookings Institution in Washington, DC, March 20 on a broad list of topics, including FDA’s fight with e-cigarette companies to ban sales of their products to...

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