Why PDUFA VIII keeps patients first and strengthens America's biopharma leadership

16 September 2026

When patients are waiting for new treatments, safety and speed both matter, according to trade group Pharmaceutical Research Manufacturers of America (PhRMA).

For over 30 years, the Prescription Drug User Fee Act (PDUFA) has delivered both — helping establish the USA as the first stop worldwide for most new medicine approvals and helping support the Food and Drug Administration’s (FDA) reputation as the global gold standard for regulatory review.

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