Patient-Focused Drug Development: Public Workshop on Guidance 1, Collecting Comprehensive and Representative Input

Food and Drug Administration

This discussion document provides a basis for discussion that will inform the development of guidance documents to facilitate collection and...

Patient-reported outcomes

2016-2017 Strategic Priorities: Partner with Patients

FDA Center for Devices and Radiological Health

Description of FDA-CDRH's Strategic Priority to increase use and transparency of patient input as evidence in our decision making and...

Patient preference

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events

National Cancer Institute

Information about a patient-reported outcome measurement system developed by the National Cancer Institute to capture symptomatic adverse events in patients...

Patient-reported outcomes NIH

Clinical Outcome Assessment Compendium

FDA Center for Drug Evaluation and Research

The compendium is intended to facilitate communication and  transparency about clinical outcome assessments by summarizing information for many different diseases...

Patient-reported outcomes

Patient-Focused Drug Development Initiative

FDA Center for Drug Evaluation and Research

Information about the FDA's Patient-Focused Drug Development initiative that aims to more systematically gather patients’ perspectives on their condition and...

Benefit-risk assessment Patient focused drug development

The Voice of the Patient

FDA Center for Drug Evaluation and Research

Voice of the Patient reports summarize the information and testimonies provided by patients and patient representatives at a series of...

Patient organizations

Patient Representative Program


Resources for individuals interested in applying to become Patient Representatives to the U.S.

Patient organizations