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

Issue Date: April 1, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Electronic Submissions,
Status: Final

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

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 This guidance finalizes the draft guidance of the same name published on October 30, 2019 (84 FR 58158), and describes the electronic format sponsors will be required to use when they electronically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)).

Download the Guidance Document