USA – FDA guidance targets REMS document e-submission

The US Food and Drug Administration (FDA) has issued final guidance on the electronic submission of documents related to the Risk Evaluation and Mitigation Strategies (REMS) using the Structured Product Labeling (SPL) format. The final guidance document starts the clock on compliance, with the new formatting requirements taking effect on 28 December 2022.

In the final guidance document, the FDA outlines how it will implement the requirements for e-submission of REMS documents that are part of submissions for new drug applications (NDAs), abbreviated new drug applications (ANDAs), and certain biologics license applications (BLAs). The SPL formatting applies to both new REMS documents and modifications…