# REMS Assessment: Planning and Reporting - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/rems-assessment-planning-and-reporting/c1fedc97-921d-4bcf-8c8f-2ea35b441b95

> FDA guidance document: REMS Assessment: Planning and Reporting. Issue date: February 01, 2019. Get complete insights and analysis.

---

## Details

- Title: REMS Assessment: Planning and Reporting
- 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: 2019-02-01
- Comment Close Date: 2019-04-02
- Last Changed: 2020-04-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-4628">FDA-2018-D-4628</a>

## Related Documents

- [Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/child-resistant-packaging-statements-in-drug-product-labeling-guidance-for-industry/6c75fc9c-8e65-49a0-ad1d-eb6162ad92b8)
- [Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection](https://www.globalkeysolutions.net/guidances/guidance-document/immunogenicity-testing-of-therapeutic-protein-products-developing-and-validating-assays-for-anti-drug-antibody-detection/ea78d6b5-b969-4817-b06b-f7e0cfa9b536)
- [Format and Content of a REMS Document Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/format-and-content-of-a-rems-document-guidance-for-industry/7d3af53b-d82d-41fe-9a2f-31d366c94701)