Announcing Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format: IND Safety Reports

Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format: IND Safety Reports and  associated technical specifications documents.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 intend 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 which is consistent with the International Council for Harmonisation 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 The FDA is issuing this draft guidance to introduce this new reporting pathway and open a comment period. The requirement will go into effect 2 years after the draft guidance is finalized.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.

The FDA is encouraging the submission of comments on this draft guidance and technical specifications documents via the associated docket (FDA-2019-D-3953). On November 1, 2019, 1:00 p.m. – 2:00 p.m. (Eastern) Agency staff will hold a webinar on submitting IND safety reports to FAERS. Registration is required.