FDA Plans To Continue Diagnostics Reform Fight
In a recent webinar about the agency’s current regulatory and legislative priorities, FDA Deputy Commissioner Andi Fristedt called the way diagnostics are now regulated “untenable.”
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Diagnostics Reform Out As Congress Reaches Year-End Omnibus Compromise
A measure that would have moved diagnostics regulation under the US Food and Drug Administration has been culled from the year-end omnibus spending package.
EPA Gives Stakeholders Additional 15 Days For EtO Comments
The deadline for comments on the Environmental Protection Agency proposal, which trade groups say could lead to device shortages if implemented, has been moved from 12 June to 27 June.
‘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.