November 19, 2025 By Julia Pian, MD Last Wednesday, the U.S. Food and Drug Administration announced   the Plausible Mechanism Pathway, outlining in broad strokes a new regulatory strategy for supporting the responsible advancement of precision genetic therapies [1]. As an independent, cross-sector non-profit, the N=1 Collaborative welcomes this move, signaling the FDA's willingness to be a creative partner in developing models to unlock the potential of precisely targeted, pr

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