# FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/fdas-application-of-statutory-factors-in-determining-when-a-rems-is-necessary/5d692a06-6650-46b8-bfbd-88782ca49625

> FDA guidance document: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary. Issue date: April 04, 2019. Get complete insights and analysis.

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## Details

- Title: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary
- 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: 2019-04-04
- Last Changed: 2019-04-05
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-2730">FDA-2016-D-2730</a>

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