Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023
Senate appropriations bill would take back some of the increase the House offered the Center for Drug Evaluation and Research and other programs, setting up negotiations as next fiscal year nears.
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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.
A new study finds the agency only approved a product despite a negative advisory committee vote six times in six years. The overall rate of agreement between the agency and advisory committees has increased since 2015.
Principal Deputy Commissioner Woodcock is overseeing an enterprise-wide technology campaign intended to improve access to agency information and data.