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# REMS Document Technical Conformance Guide
- URL: https://www.fdaweb.com/rems-document-technical-conformance-guide/
- Published: 2023-01-05T12:00:00.000Z
- Updated: 2026-09-14T18:10:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153479

FDA has published a *REMS Document Technical Conformance Guide* to supplement a guidance on the *Format and Content of a REMS Document*. The conformance guide provides technical recommendations to applicants to draft a REMS. It is intended to complement and promote interactions between applicants and FDA. However, it says, it is not intended to replace the need for applicants to communicate directly with review staff regarding implementation approaches or issues relating to their REMS. “The use of these templates is expected to improve efficiency of the review process for REMS,” the [guide](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/rems-document-technical-conformance-guide?ref=fdaweb.com) says.