Diagnostics Reform Reintroduced in House
The VALID Act, which will hand diagnostics oversight to the US FDA, has been reintroduced in the House of Representatives after it failed twice last year in Congress.
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‘Wait-and-See Time’: Panel Predicts Limited Congressional Action On Devices This Year
An expert panel at the FDLI annual meeting expects the US Congress to want to see more results from recent legislation on devices before it moves ahead with further FDA reform. Though, pandemic-related measures remain a priority.
Shuren: ‘You Can’t Be Expecting Us To Just Sit Back’
In a wide-ranging speech at FDLI’s 2023 annual meeting, CDRH director Jeffrey Shuren pledged to move forward with regulatory action on lab-developed tests and sketched plans for improved regulation of medical apps.
What Should Be Included In PAHPA's Reauthorization?
At the first meeting of the Capitol Hill steering committee on pandemic preparedness, experts weighed in on what they hope to see in PAHPA’s reauthorization.