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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
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 This draft guidance and the Structured Product Labeling (SPL) implementation guide describe the requirements for the electronic submission of the content of a risk evaluation and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 This draft guidance describes how FDA plans to implement the requirements for the electronic submission of REMS documents as part of submissions under new drug applications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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-E-4282.