FDA Output
FDA Output, May 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in May 2026. Updated May 19.
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Business Strategies
Biologically Focused Development Increases Success
On a panel at the annual Dublin Innovation Summit engaged stakeholders discuss the benefits and challenges of gathering deep data during the development and testing of therapies and diagnostics, specific to the gender of the patients who will benefit from the medical interventions.
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Regulatory & Reimbursement
Pathways' Pick of the Week: Billion-Dollar Budget
User fees would bankroll more than half of the FDA’s FY2027 budget request. Excerpted from Pathways’ Picks April 7: Shuren Venture Fund, MDUFA Agreement, Global Digital Health Updates.