# Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/patient-focused-drug-development-incorporating-clinical-outcome-assessments-into-endpoints-for-regulatory-decision-making/602cd947-34b1-41f2-adaf-e98010054159

> FDA guidance document: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making. Issue date: April 05, 2023. Get complete insights and analysis.

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## Details

- Title: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
- 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: 2023-04-05
- Comment Close Date: 2023-07-05
- Last Changed: 2023-04-05
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-0026">FDA-2023-D-0026</a>

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