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

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

Information for industry

• Draft guidance - Providing Regulatory Submissions in Electronic Format: IND Safety Reports - Describes the electronic format sponsors will be required to use when they electronically submit to FDA 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). Comment by December 30, 2019. Also see: FDA Adverse Event Reporting System (FAERS) Electronic Submissions (October 29, 2019)