RAPS

PFDD: FDA finalizes guidance on identifying what’s important to patients

The US Food and Drug Administration (FDA) on Friday finalized guidance to assist sponsors collect and submit “important” information from patients and caregivers used for medical product development ...
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 ...
RAPS

Is FDA Listening Enough to Patients? Agency Wants Feedback

When Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, its patient-centered provisions were among the biggest changes set to impact the culture of ...
MarketWatch

Foundation for Sarcoidosis Research Publishes Comprehensive Voice of the Patient Report Following Externally Led PFDD Meeting with the FDA

The MarketWatch News Department was not involved in the creation of this content. CHICAGO, Dec. 18, 2025 (GLOBE NEWSWIRE) -- The Foundation for Sarcoidosis Research (FSR) is proud to announce the ...