November 4, 2019Regulatory
The FDA 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 The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents.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.
According to the FDA, the Technology Modernization Action Plan (TMAP) includes modernizing FDA's technical infrastructure in ways that allows FDA to receive, analyze, and use data in new ways to advance the FDA's regulatory mission. 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 The publication of the draft guidance and technical documents should assist sponsors in beginning preparations for when the draft guidance is finalized and effective.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 Harmonization 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.
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.