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Gottlieb Defends US FDA 2019 Budget, Device Safety Plan In House

 
• By Sue Darcey

Members of a US House Appropriations Subcommittee interrogated FDA Commissioner Scott Gottlieb on the agency's proposed 2019 budget and his newly released device safety plan. One fierce critic, Rep. Rosa DeLauro, D-RI, attacked Gottlieb's efforts to allow third-party certifiers to approve device quality manufacturing processes, and said his safety plan looked like a "high-risk" action plan.

While US FDA Chief Scott Gottlieb's ongoing reforms and the agency's FY 2019 budget requests were well-received by most members of a House Appropriations Subcommittee hearing on April 17, some on the panel said Gottlieb's budget priorities would relax regulations too much.

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More from Policy & Regulation

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• By Elizabeth Orr

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Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.