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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Rare disease advocates push for National Academies of Sciences, Engineering and Medicine study on how or whether ultra-rare should be defined, which could create legislative pressure. In an interview, Ultragenyx CEO Emil Kakkis suggests patient thresholds, accelerated approval triggers.
FDA Commissioner Robert Califf says the medical product programs have received a lot of attention and now it’s the food program’s turn.
With Congress watching whether enough experts are on advisory committees for orphan drugs, the US FDA may be pressured into changes.