US FDA proposes formal performance metrics for REMS assessment reviews, which would be part of a larger campaign to streamline the REMS assessment process.
Risk Evaluation and Mitigation Strategy assessments may be subject to performance goals under the next prescription drug user fee program.
Food and Drug Administration officials also have indicated they want funding to speed up the REMS assessment process. As part...
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
