# Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/patient-focused-drug-development-selecting-developing-or-modifying-fit-for-purpose-clinical-outcome-assessments/1446031c-eaef-4950-81f7-ebe3db10d88b > FDA guidance document: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. Issue date: October 22, 2025. Get complete insights and analysis. --- ## Details - Title: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments - Communication Type: Guidance Document - Product Type: drugs - Office Name: Center for Drug Evaluation and Research - Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c - Issue Date: 2025-10-22 - Last Changed: 2025-11-17 - Docket Number: FDA-2022-D-1385 ## Related Documents - [Patient-Focused Drug Development: Methods to Identify What Is Important to Patients: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders](https://www.globalkeysolutions.net/guidances/guidance-document/patient-focused-drug-development-methods-to-identify-what-is-important-to-patients-guidance-for-industry-food-and-drug-administration-staff-and-other-stakeholders/06de176c-365a-43ad-84f7-7aa3926833b5) - [Digital Health Technologies for Remote Data Acquisition in Clinical Investigations](https://www.globalkeysolutions.net/guidances/guidance-document/digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations/d03b5a1b-cf30-4bed-81a8-aa883ea62d4c) - [Patient-Focused Drug Development: Collecting Comprehensive and Representative Input](https://www.globalkeysolutions.net/guidances/guidance-document/patient-focused-drug-development-collecting-comprehensive-and-representative-input/abbf838a-9294-4c1b-a0d1-55c963831af5)