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GUIDANCE DOCUMENT

Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry April 2024

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2019-D-3953
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Oncology Center of Excellence

FDA is announcing the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format:  IND Safety Reports.”  This guidance finalizes the draft guidance of the same name published on October 30, 2019 (84 FR 58158), and describes the electronic format sponsors will be required to use when they electronically submit IND safety reports to CDER and CBER for serious and unexpected suspected adverse reactions, as required under 21 CFR 312.32(c)(1)(i).  FDA is establishing the electronic format requirements described in this final guidance under section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)).

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Submit Comments Online

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:

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.

 
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