In a draft guidance issued Tuesday, the US Food and Drug Administration (FDA) details how drugmakers can gather comprehensive and representative input from patients. "FDA recognizes the need to engage ...
Final guidance for drugmakers on gathering comprehensive and representative input from patients is now available from the US Food and Drug Administration (FDA). The guidance outlines what constitutes ...
Explore how patient experience data shapes regulatory drug decisions, enhancing the patient-focused drug development initiative for better treatment outcomes. Patient experience data are critical to ...
On October 23, 2025, FDA released its final guidance regarding Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The guidance is the ...
In December 2016, the bipartisan 21st Century Cures Act (P.L. 114-255) was enacted, marking a pivotal milestone in advancing a patient-focused drug development (PFDD) paradigm. This law directed the ...
Patient preference studies (research into what patients value in their treatment) are increasingly used to inform drug development and regulatory approval decisions. But these studies are expensive ...
Medical patients can thought of as benchwarmers – closer even to spectators – in the healthcare game, watching pharmaceutical companies, large physician practice groups, and insurance companies call ...
Why is there growing urgency around outcome measures in clinical research? Over the past decade, regulators have made it clear that patient experience data isn’t simply a “nice to have,” but rather, a ...
Patient engagement has matured from aspiration to necessity as precision medicine moves from laboratory concept to bedside. Cutting-edge therapies increasingly target narrowly defined genetic or ...
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