On December 18th, FDA is conducting a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA to inform regulatory decision-making may use. The workshop will focus on topics related to approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act and to meet a performance goal included in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VI).

The purpose of this public workshop is to obtain feedback from stakeholders on consideration for:

(1) Standardized nomenclature and terminologies for patient-focused drug development

(2) Methods to collect meaningful patient input throughout the drug development process

(3) Methodological consideration for data collection, reporting, management, and analysis of patient input

FDA is seeking information and comments from a broad range of stakeholders, including patients, patient advocates, academic and medical researchers, expert practitioners, drug developers and other interested persons. Approximately one month before the workshop, FDA will publish a discussion document that outlines potential approaches and methodological considerations for data collection, reporting, management, and analysis of patient input. FDA will be specifically interested in obtaining your comments on the approaches and considerations proposed in the discussion document during the workshop.

Please visit the FDA website for the workshop for additional information and meeting materials.