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In a draft guidance issued Tuesday, the US Food and Drug Administration (FDA) details how drugmakers can gather comprehensive and representative input from patients.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

FDA Issued Updated Patient-Focused Drug Development Guidance on Clinical Outcome Assessments

The U.S. Food and Drug Administration (FDA) issued its third Patient-Focused Drug Development (PFDD) guidance titled, “Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments ...
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 Westside Gazette

Sickle Cell Disease Association of America Inc. Hosts Externally Led Patient-Focused Drug Development Meeting on Sickle Cell Disease

The Sickle Cell Voices Alliance, a partnership of the Sickle Cell Disease Association of America Inc., the Sickle Cell ...
PharmTech

Q&A: Patient-Centric Drug Development Should Start at Product Definition

Medication nonadherence remains one of the widest gaps between how a drug performs in clinical trials and how it performs in ...
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 ...
FiercePharma

Eight Trends Reshaping Patient-Centric Drug Development

Across two Patients as Partners advisory board discussions, leaders from pharma, CROs, patient advocacy organizations, and community engagement groups described an industry that has largely moved ...
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 ...
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 ...