Digital submission of adverse event reports for investigational new drug applications

FDAThe U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS). The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents. The changes will allow the FDA to access and review both pre- and post-market safety information in the same system and with the same data standard.

"In September, the FDA rolled out our Technology Modernization Action Plan (TMAP), an ambitious strategy that includes modernizing our technical infrastructure in ways that allow us to receive, analyze, and use data in new ways to advance the FDA's regulatory mission," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. "One way we are working to meet this goal is by designing technical interfaces and tools to enable the streamlined submission and review of data. Creating standard, digital IND safety reports is an important step toward more sophisticated data and technology solutions at the FDA to support efficient development of safe and effective medical products."

The guidance outlines the FDA’s intent to implement a standard digital framework for the electronic submission, review and tracking of certain IND safety reports in FAERS. The publication of the draft guidance and technical documents should assist sponsors in beginning preparations for when the draft guidance is finalized and effective. IND safety reports will be submitted using a data standard known as ICH E2B. This will provide sponsors with a reporting format that is consistent with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and consistent with reports used by other regulatory agencies. The FDA will soon announce when sponsors can begin to voluntarily submit IND safety reports to FAERS.

"Currently, sponsors of IND applications are required to submit IND safety reports to the FDA, which are submitted for review via a standardized form that is received either in paper format or electronically as a PDF. Review and tracking of these reports in paper or PDF format is inefficient and labor intensive," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The submission of this important 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. The FDA highly encourages sponsors of all INDs, both commercial and noncommercial, to begin submitting IND safety reports to FAERS voluntarily as soon as the new submission process is available."

IND safety reporting via FAERS will be voluntary until two years after the finalization of the guidance, at which point it will be mandatory for sponsors of commercial INDs that make electronic submissions. Once the requirement is in effect, sponsors will be required to submit certain IND safety reports to FAERS instead of in eCTD format. There will be two options for submission, directly to FAERS and via the Safety Reporting Portal, a web-based submission system that feeds into FAERS.

This guidance does not affect the criteria sponsors must use to determine if an IND safety report must be submitted, timelines for reporting, or other elements of IND safety reporting requirements. Because IND data, including clinical trial information, is proprietary and generally not releasable from the FDA, IND safety reports will not be made publicly available. The FDA has created a separate submission path to FAERS for IND safety report submissions so that they remain designated as investigational in FDA’s internal recordkeeping system.

The digital framework for IND safety reports was conceived and piloted under the FDA’s Information Exchange and Data Transformation (INFORMED) Program. Working with the FDA's Oncology Center of Excellence, in collaboration with the FDA's Center for Drug Evaluation and Research's Office of Surveillance and Epidemiology and the FDA's Center for Biologics Evaluation and Research, several sponsors submitted IND safety reports using the piloted digital framework in parallel to the standard submission process to inform the process. The FDA analyzed results and used the feedback from sponsors to optimize the process for submitting safety reports electronically using the new framework.

As part of the TMAP, the FDA is expanding its capability to develop technology products through a series of projects that demonstrate new ways of applying technology and data to the FDA's regulatory mission. These projects will span the FDA's broad regulatory responsibilities - from supporting innovation in medical product development to bringing new ways to ensure food safety and increase the effectiveness of the FDA's field operations. This work will build on the success of INFORMED and similar programs through a new, forward-looking program called CoInnovate@FDA. Designed to be an incubator of modern technology and data projects, CoInnovate@FDA will connect work from across the FDA and the broader learning health system.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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