RAPS

Patient Focused Drug Development: FDA Issues Guidance on Gathering Patient Input

In a draft guidance issued Tuesday, the US Food and Drug Administration (FDA) details how drugmakers can gather comprehensive and representative input from patients.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 ...
RAPS

Patient-Focused Drug Development: New FDA Draft Guidance Delves Into What’s Important

The US Food and Drug Administration (FDA) on Monday published the second in a series of four guidance documents on patient-focused drug development, with this latest draft helping sponsors identify ...
JD Supra

FDA Seeks Feedback on Patient-Focused Drug Development

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 ...
The American Journal of Managed Care

How Patient Voices Shape Regulatory Drug Decisions: Eleanor Perfetto, PhD

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 ...
Medical Xpress

Old data can transform the future of health care

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 ...
Health Affairs

To Enhance Rare Disease Patient Engagement, The Food And Drug Administration Must Reckon With Industry Influence

The agency has failed to consider ways in which industry influence can shape the patient voices that the FDA hears. Once seen as radical, the idea that patient communities should play a meaningful ...