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# FDA Begins Accepting REMS in SPL Format Next Month
- URL: https://www.fdaweb.com/fda-begins-accepting-rems-in-spl-format-next-month/
- Published: 2016-08-25T12:00:00.000Z
- Updated: 2026-09-14T21:26:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136616

FDA says it will begin accepting 9/3 Risk Evaluation and Mitigation Strategies (REMS) documents in “structured product labeling (SPL)” formats as a means to standardize the documents and eventually integrate them into electronic healthcare records. Currently, there are 75 approved REMS, with 42 of those having the most restrictive “elements to assure safe use,” CDER Office of New Drugs senior advisor **Adam Kroetsch** said during a 8/24 [webinar](https://concerted.adobeconnect.com/p45n3m5cdi9/?ref=fdaweb.com).  

The agency is preparing a draft guidance to help sponsors with their SPL submissions, which will become mandatory two years after a final guidance is published, Kroetsch said. Sponsors submitting an NDA that includes a REMS or if they are modifying an existing REMS should submit the SPL file through the FDA gateway under the electronic common technical document. “As soon as you know your intent to submit in SPL format, reach out to the REMS Website team at *FDA\_REMS\_Website@fda.hhs.gov*,” he said. For sponsors converting an already-approved REMS to SPL format, they should still contact the REMS Website team and submit the file to FDA’s eList.

Once sponsors contact the team, they will be provided an implementation guide, a REMS terminology guide, an Xforms tool to create SPL documents, and an example document showing successfully completed REMS SPL files, Kroetsch told the webinar audience. Additional resources to assist sponsors include:

• [Structured Product Labeling (SPL) Implementation Guide with Validation Procedures](http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM321876.pdf?ref=fdaweb.com)

• [The FDA’s REMS Integration Initiative](http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm350852.htm?ref=fdaweb.com)