Rare Disease Expertise On FDA Advisory Committees Gains Capitol Hill Attention
With Congress watching whether enough experts are on advisory committees for orphan drugs, the US FDA may be pressured into changes.
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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.
US FDA Neurology Drugs Program Gains Boost In FY 2023 Funding Bill Amid Calls To Clarify Development Policies
US FDA gains a nearly 7% increase in non-user fee funding, some of which will go for neurology drug guidance.
Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity, but it does not give the agency authority to mandate postmarketing studies if a preapproval trial falls short of demographic diversity goals.