# Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/risk-evaluation-and-mitigation-strategies-modifications-and-revisions-guidance-for-industry/97c2bcd1-cfbd-4928-92c1-d3ac287909b5

> FDA guidance document: Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry. Issue date: July 09, 2019. Get complete insights and analysis.

---

## Details

- Title: Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2019-07-09
- Last Changed: 2020-06-29
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-1747">FDA-2014-D-1747</a>

## Related Documents

- [Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/limited-population-pathway-for-antibacterial-and-antifungal-drugs-guidance-for-industry/f01d33af-ed26-4eb5-961a-03e00c90f2c7)
- [Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/qualification-process-for-drug-development-tools-guidance-for-industry-and-fda-staff/f5a3f8af-54f6-44ba-9eea-d3cc587444f7)
- [Q2(R2) Validation of Analytical Procedures](https://www.globalkeysolutions.net/guidances/guidance-document/q2r2-validation-of-analytical-procedures/2fb8b117-5251-4360-87db-a581ceb120a0)