E-Submissions of REMS Documents: FDA Offers Draft Guidance

The US Food and Drug Administration (FDA) on Friday released draft guidance describing how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications.

The agency said the implementation will begin no earlier than 24 months after issuance of the final guidance.

The 7-page draft explains how certain REMS documents will be required to be submitted in electronic format using Structured Product Labeling (SPL) (also see FDA guidance titled: "Structured Product Labeling (SPL) Implementation Guide with Validation Procedures").

FDA said some stakeholders previously expressed the need to have better ways to integrate REMS materials and procedures into their existing data systems and health care delivery processes.

"Stakeholders also expressed the desire to avoid spending excessive time trying to locate, understand, and comply with different REMS requirements while ensuring safe use of drugs with REMS," the guidance says. To help address these concerns, FDA intends to require applicants of NDAs, ANDAs, and BLAs to submit the content of their REMS documents in Structured Product Labeling (SPL) format."

Development of this guidance was facilitated as part of a project known as "REMS Integration Initiative," (see more from the 2014 report, "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS).")

Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling