In a recent STAT News opinion piece, BIO President & CEO John F. Crowley calls for strategic FDA reform to accelerate rare disease therapies while preserving regulatory expertise. He cautions against deep staffing cuts, stating, “If the FDA and other agencies lose their most knowledgeable employees…patients in need will suffer.”

Crowley highlights recent FDA progress, such as the Rare Disease Innovation Hub and stresses the need for strong leadership to sustain momentum.

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