FDA to urge electronic submission of product safety reports

The Food and Drug Administration is moving toward requiring more electronic submissions of safety reports for products being evaluated by the agency.

The goal is to enable FDA to access and review pre-market and post-market safety information in the same information system and with the same data standards.

Products will be evaluated under an Investigational New Drug application (IND) into the FDA’s Adverse Event Reporting System, known as FAERS. The government also is offering supporting technical specification documents.


Modernizing the technical infrastructure will enable regulators to receive, analyze and use data in new ways to advance the regulatory mission, says Amy Abernethy, MD.

“One way to meet this goal is by designing technical interfaces and tools to enable the streamlined review, submission and review of data,” Abernethy adds. “Creating standard digital IND safety reports is an important step toward more sophisticated data and technology solutions to support efficient development of safe and effective medical products.”

IND safety reports will be submitted using a data standard known as ICH E2B, which offers sponsors specific governing guidelines covering pharmaceuticals for human use. FDA anticipates to soon allow sponsors to voluntarily submit IND safety reports to the FAERS system.

For now, however, sponsors are required to submit safety reports via a standardized paper format or electronically as a PDF, but that soon will change, according to Janet Woodcock, MD, director at the FDA Center for Drug Evaluation and Research.

“Submission of this safety information as electronic data in structured data elements will improve the FDA’s ability to review and track the safety signals that occur during the conduct of clinical trials,” Woodcock explains. “The FDA highly encourages sponsors of commercial and noncommercial INDs to begin submitting IND safety reports to the FAERS system voluntarily as soon as the submission process is available.”

There will be two options for submission—directly to FAERS or via a safety reporting portal that is a web-based submission that feeds into FAERS.

Because IND data including clinical trial information is proprietary and generally not releasable from FDA, the IND safety reports will not be publicly available. FDA has unveiled a separate submission path for IND safety submissions so they remain designated as investigational material in FDA’s internal recordkeeping system.