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 ...
RAPS

FDA finalizes guidance on patient-focused drug development

The US Food and Drug Administration (FDA) has finalized guidance on patient-focused drug development (PFDD), outlining approaches for sponsors to select, modify, and evaluate clinical outcome ...
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 ...
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 ...

Adial Pharmaceuticals Submits Application to FDA Commissioner’s National Priority Voucher (CNPV) Pilot Program for AD04 Clinical Development Program

Voucher application details focus on AUD as a major driver of the U.S. substance use crisis and the genetic targeting of AD04 ...
EurekAlert!

New study on early Parkinson’s disease progression highlights vital role of patient focused drug development and real-world impacts

TUCSON, Ariz., March 10, 2026– Critical Path Institute® (C-Path) applauds the publication of a new study in the Journal of Neurology that offers critical longitudinal insights into how symptoms and ...