Democrats are raising concerns that the continuing resolution intended to fund the government for the remainder of fiscal year 2025 gives Trump too much power, though it is unclear whether the FDA would be as impacted as other agencies.
The US Food and Drug Administration would see its second straight year without a boost in taxpayer funds in at...
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.
An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
