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# 2nd Patient-Focused Drug Development Guidance
- URL: https://www.fdaweb.com/2nd-patient-focused-drug-development-guidance/
- Published: 2022-03-01T12:00:00.000Z
- Updated: 2026-09-14T17:34:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151258

FDA has published a guidance, *Patient-Focused Drug Development: Methods to Identify What is Important to Patients*, describing approaches to identifying what is most important to patients concerning their experience as it relates to the burden of disease/condition and burden of treatment. The [document](https://www.fda.gov/media/131230/download?ref=fdaweb.com) is the second in a series of four methodological patient-focused drug development guidances that FDA says describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.

The guidance’s contents are Introduction, Methods to Identify and Understand What is Important to Patients, Qualitative Research Methods, Mixed Methods, Managing Barriers to Self-Report, Considerations for Use of Social Media, five appendices, and seven tables.