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GUIDANCE DOCUMENT

Providing Regulatory Submissions in Electronic Format: IND Safety Reports: Guidance for Industry October 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
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-2019-D-3953


Docket Number:
FDA-2019-D-3953
Issued by:
Guidance Issuing Office
Center 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This draft guidance describes the electronic format sponsors will be required to use when they electronically submit to the Food and Drug Administration (FDA or Agency)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.