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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This draft guidance describes the electronic format sponsors will be required to use when they electronically submit to the Food and Drug Administration (FDA or Agency) investigational new drug application (IND) safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 21 CFR 312.32(c)(1)(i). FDA is establishing the electronic format requirements described in this guidance under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will supersede the effective version of the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (“eCTD Guidance”) for the submission of IND safety reports required under 21 CFR 312.32(c)(1)(i) that are within the scope of this guidance (see section III., Scope of This Guidance). This guidance will not replace any requirements in the eCTD Guidance other than those relating to the submission of IND safety reports required under 21 CFR 312.32(c)(1)(i) that are within the scope of this guidance. This guidance also references several technical specification documents, which provide additional details regarding the format for electronic submission of IND safety reports to FAERS.