Articles
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2 weeks ago |
insights.citeline.com | Brian Bossetta
End Of The Road? Court LDT Decision May Leave FDA With Few Options Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?
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3 weeks ago |
insights.citeline.com | Brian Bossetta
FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.
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3 weeks ago |
insights.citeline.com | Elizabeth Orr |Shubham Singh |Brian Bossetta |Marion Webb
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3 weeks ago |
insights.citeline.com | Brian Bossetta |Elizabeth Orr
Staff Cuts At CDRH Focus On Administrative Workers, Spare ReviewersAbout 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale. (Cagkan Sayin/Shutterstock)
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3 weeks ago |
insights.citeline.com | Brian Bossetta
LDT Saga Comes To A Grinding Halt As Judge Sides With Labs, Vacates FDA’s Final Rule A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.
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