US FDA’s Long Wait For Diagnostics Reform Legislation Continues
FDA is hoping Congress might take up proposed legislation governing the regulation of diagnostic tests produced in laboratories in 2023. That will make it a full decade of stalemate since FDA outlined a framework to address the new reality of personalized medicine.
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FDA Reforms Missed By FDORA Could Find Vehicle In Animal Drug User Fee, Pandemic Bills
The usually lower-profile user fee reauthorizations could gain more attention for broader US FDA issues, said Andi Lipstein Fristedt, FDA deputy commissioner for policy, legislation and international affairs.
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.
Expect FDA Diagnostics-Reform Bill Passage In 2019, Rep. DeGette Says
Passage of a US FDA diagnostics reform bill is one priority for the US House Energy and Commerce Committee in 2019, said cosponsor and committee member Rep. Diana Degette, D-Colo.