# Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/patient-reported-outcome-measures-use-in-medical-product-development-to-support-labeling-claims-guidance-for-industry/506b29a8-b7ee-47d9-b155-79fd4d5b76e2

> FDA guidance document: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims:  Guidance for Industry. Issue date: December 09, 2009. Get complete insights and analysis.

---

## Details

- Title: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2009-12-09
- Last Changed: 2020-05-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2006-D-0362">FDA-2006-D-0362</a>

## Related Documents

- [Drug-Induced Liver Injury: Premarketing Clinical Evaluation](https://www.globalkeysolutions.net/guidances/guidance-document/drug-induced-liver-injury-premarketing-clinical-evaluation/de53c59a-0e5e-4eeb-9106-8a5a0947edbc)
- [Systemic Lupus Erythematosus --Developing Medical Products for Treatment](https://www.globalkeysolutions.net/guidances/guidance-document/systemic-lupus-erythematosus-developing-medical-products-for-treatment/067dc730-0e77-42b9-a240-78f5dae2130b)
- [Electronic Source Data in Clinical Investigations:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/electronic-source-data-in-clinical-investigations-guidance-for-industry/6d72d592-c70b-47f5-810c-0542a685c1b5)