FDA Draft Guidance: Providing Regulatory Submissions in Electronic Format: IND Safety Reports

The FDA just issued draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format: IND Safety Reports and associated technical specifications documents. The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research intends to implement a digital framework for the electronic submission, review, and tracking of certain investigational new drug (IND) safety reports.

This framework will improve the FDA’s ability to detect, track, and act upon safety signals that occur during clinical trials. It will also provide sponsors with a more efficient reporting mechanism that is consistent with ICH guidelines and reporting to other regulatory agencies. In the future, the agency will require certain IND safety reports to be submitted electronically to the FDA Adverse Event Reporting System (FAERS). The FDA is issuing this draft guidance to introduce this new reporting pathway and open a comment period. The requirement will go into effect 2 years after the draft guidance is finalized. Prior to going into effect, IND safety reporting to FAERS will be voluntary; however, the FDA highly encourages sponsors to begin this more efficient submission process via FAERS as soon as the system begins accepting IND safety reports electronically.

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