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Hahn: FDA May Keep Some COVID-19 Reforms Post-Pandemic

 
• By Elizabeth Orr

US FDA commissioner Stephen Hahn said during an 18 June “fireside chat” that he expects closer relationships with industry and a greater reliance on postmarket data to continue even after the COVID-19 pandemic comes to an end.

Stephen Hahn in his 1st address to the FDA January 30, 2020
Stephen Hahn

Changes made in response to the COVID-19 pandemic may be here to stay at the US Food and Drug Administration, commissioner Stephen Hahn said in a presentation organized as part of the Medical Device Innovation Consortium (MDIC)’s annual public forum on 18 June.

Hahn, who was sworn in as head of the agency last December, had only a few months as commissioner under...

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The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

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More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

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• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.