Multiple congressional offices attended a briefing on GDUFA III with FDA and industry officials, suggesting plans for the must-pass bill already are in the works.
Negotiations to reauthorize the generic drug user fee program have not been completed, but Capitol Hill already is interested in the final product.
Multiple congressional offices received a briefing from the US Food and Drug Administration and industry representatives on 27 May about...
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.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
