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Rare Disease Expertise On FDA Advisory Committees Gains Capitol Hill Attention

 
• By Derrick Gingery

With Congress watching whether enough experts are on advisory committees for orphan drugs, the US FDA may be pressured into changes.

Expert stamp
The FDA is streamlining advisory committee member recruitment and retention and developing other process improvements. • Source: Shutterstock

Congress is not ready to force the US Food and Drug Administration to designate rare disease expertise for relevant advisory committee meetings, but lawmakers now seem to be paying closer attention to advocates’ long-time complaints about the issue, which could increase the pressure on the agency to make changes.

A provision tucked into the explanatory statement attached to the

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