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 a final guidance in which the Food and Drug Administration (FDA or Agency) 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 This draft guidance and the Structured Product Labeling (SPL) implementation guide describe the requirements for the electronic submission of the content of a risk evaluation and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 This draft guidance describes how FDA plans to implement the requirements for the electronic submission of REMS documents as part of submissions under new drug applications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 certain biologics license applications (BLAs). Pursuant to section 745A(a), beginning 24 months after this guidance is finalized, REMS documents that are not submitted electronically in accordance with the final guidance will not be filed or received.
In section 745A(a) of the FD&C Act, Congress granted explicit authorization to FDA to implement the statutory electronic submission requirements in guidance. Accordingly, as indicated by the use of the words must or required, this draft guidance is not subject to the usual restrictions in FDA’s good guidance practices (GGP) regulation, such as the requirement that guidances not establish legally enforceable responsibilities (see 21 CFR 10.115(d)).
To comply with the GGP regulations and make sure that regulated entities and the public understand that guidances are nonbinding, FDA guidances ordinarily contain standard language explaining that guidances should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. FDA is not including this standard language in this guidance because the language is not an accurate description of the effects of this guidance. Insofar as this guidance specifies the format for electronic submission of REMS documents under section 745A(a) of the FD&C Act, it will have binding effect, 24 months after the publication of the final guidance in the Federal Register.