> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on Patient-Focused Drug Development
- URL: https://www.fdaweb.com/guide-on-patient-focused-drug-development-3/
- Published: 2019-09-30T12:00:00.000Z
- Updated: 2026-09-15T01:53:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145124

FDA has made available a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-methods-identify-what-important-patients-guidance-industry-food-and?ref=fdaweb.com) on “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients.” The document describes how stakeholders (patients, researchers, medical product developers and others) 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. It also discusses methods to identify what matters most to patients regarding burden of disease and burden of treatment to guide medical product development, including endpoint development.