US FDA’s priority review voucher fee will decrease again in FY 2022 as the cost of a priority assessment continues to trend closer to the cost of a standard assessment.
The difference between the cost of standard and priority assessments continues to narrow, a signal not only of the growing popularity of expedited pathways, but also that the US Food and Drug Administration eventually may not need a full 12 months to determine the fate of an application.
Embedded in the calculations for the FY 2022 material threat medical countermeasure, rare pediatric disease, and tropical...
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free 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.
