# Drug-Induced Liver Injury: Premarketing Clinical Evaluation - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/drug-induced-liver-injury-premarketing-clinical-evaluation/de53c59a-0e5e-4eeb-9106-8a5a0947edbc

> FDA guidance document: Drug-Induced Liver Injury: Premarketing Clinical Evaluation. Issue date: July 29, 2009. Get complete insights and analysis.

---

## Details

- Title: Drug-Induced Liver Injury: Premarketing Clinical Evaluation
- 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: 2009-07-29
- Last Changed: 2019-10-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2008-D-0128">FDA-2008-D-0128</a>

## Related Documents

- [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)
- [Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document](https://www.globalkeysolutions.net/guidances/guidance-document/integrated-summaries-of-effectiveness-and-safety-location-within-the-common-technical-document/d5fec113-5b34-45f5-bbbd-3dfd74cb580b)
