Trump Criticizes FDA For 'Slow' Approvals In Speech To Congress

In his first address to a joint session of Congress, Trump spoke of a need to "slash the restraints" at US FDA and other regulatory agencies, and he reminded legislators about his executive order to eliminate two regulations for each new one written. The president's anti-regulatory posture comes as the White House is expected to seek budget cuts for domestic agencies.

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President Trump, in his first speech to a joint session Congress Feb. 28, criticized FDA's approval process as a barrier to new medical innovations.

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South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
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A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.