Electronic Submission of IND Safety Reports Technical Conformance Guide Guidance for Industry April 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2018-D-1216
• Issued by: Center for Drug Evaluation and Research; Oncology Center of Excellence; Center for Biologics Evaluation and Research

This Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic investigational new drug application (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).  This Guide supplements the draft guidance for industry Providing Regulatory Submissions in Electronic Format: IND Safety Reports (October 2019), which implements the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to electronic submissions for certain IND safety reports submitted to CDER or CBER.

 

 

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