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.
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With Congress watching whether enough experts are on advisory committees for orphan drugs, the US FDA may be pressured into changes.
The director of the US FDA’s Center for Drug Evaluation and Research acknowledged that the FDA cannot improve trial diversity alone.
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.