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

On 23 December 2020 the FDA published the final guidance for industry.

Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(a)), beginning no earlier than 24 months after the issuance of this final guidance in which the FDA has specified the electronic format for submitting certain submission types to the Agency, the content of such submission types must be submitted electronically, and in the format specified by FDA. This guidance describes the format requirements for the electronic submission of the content of a risk evaluation and mitigation strategy (REMS) document under section 745A(a) of the FD&C Act. This guidance describes how FDA will implement the requirements for the electronic submission of REMS documents as part of submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and, as described in Section III, certain biologics license applications (BLAs). Consistent with section 745A(a) of the FD&C Act, beginning 24 months after the issuance of this final guidance, REMS documents must be submitted to FDA in structured product labeling (SPL) format.

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