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# Standardizing REMS Information in SPL
- URL: https://www.fdaweb.com/standardizing-rems-information-in-spl/
- Published: 2023-01-10T12:00:00.000Z
- Updated: 2026-09-14T18:11:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153507

CDER Office of Medication Error Prevention and Risk Management director **Claudia Manzo** says stakeholders have observed that the older REMS (risk evaluation and mitigation strategy) document format was not standardized or structured and generally could not be easily searched, queried, or managed. They suggested using structured product label (SPL) as a standard that may allow for a centralized, standardized REMS information repository.

Writing in a CDER online [post](https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-risk-evaluation-and-mitigation-strategies-rems?ref=fdaweb.com), Manzo says the agency responded to the suggestion by developing a guidance on providing regulatory submissions in electronic format.

The guidance, she says, describes the format requirements for the electronic submission of a REMS document’s content and how the agency will implement requirements for the electronic submission of a REMS document in NDAs, ANDAs, and certain BLAs.

“Arranging of REMS content and elements to assure safe use into SPL is a major first step in standardizing REMS into a granular, computable format,” Manzo writes. “As REMS sponsors submit and update their REMS documents into SPL. SPL will allow for downstream users, such as drug information resources and health systems, to more readily identify REMS drugs and incorporate the REMS requirements into end-user systems like electronic health records and pharmacy information management systems.”