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In a draft guidance issued Tuesday, the US Food and Drug Administration (FDA) details how drugmakers can gather comprehensive and representative input from patients.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

FDA’s first patient-focused drug development guidance now final

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 ...
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 ...
JD Supra

FDA Presses Forward on Patient-Focused Drug Development, Releases Final Guidance Focused on Fit-For-Purpose Clinical Outcome Assessments

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 ...
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 ...
BioSpaceOpinion

Opinion: Converting nonresponder insights into smarter drug development strategies in immunology

While agents like AbbVie's Humira have transformed the treatment landscape, not all patients benefit equally from the drug.
Nature

Optimising patient centred drug development to realise impact

Patient-reported outcomes can provide valuable evidence on the efficacy and tolerability of treatments throughout the drug development pipeline supporting regulatory decision-making, reimbursement and ...
Nature

A guide to effective drug development through nonprofit models

Patient organizations are reshaping rare disease drug development where conventional systems falter by integrating patient expertise, scientific stewardship, R&D infrastructure and cross-sector ...
MobiHealthNews

Ametris expands obesity drug development project with pharma companies

Ametris (formerly ActiGraph) has launched its second Digital Endpoint Collaboration Outcome Development (DECODE) working group for the purpose of enhancing drug development for obesity. The ...
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

A Patient-Centered Pathway For Biomedical Innovation And Access

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 ...