The U.S. Food and Drug Administration (FDA) has updated its Adverse Event Reporting System (FAERS) for the electronic submission of Individual Case Safety Reports (ICSRs). The agency has posted a series of documents and technical specifications to help prepare the industry for the electronic transmission of both pre- and post-marketing safety reports.
For pre-marketing safety reporting, the FDA has posted draft guidance for the industry and a technical conformance guide.
FDA E2B(R3) Core and Regional Data Elements and Business Rules (January 2023)
FDA ICSR XML Instances (January 2023)
However, at present, the agency is not accepting pre-market ICSRs in the E2B(R3) format. Sponsors should continue to submit IND safety reports in the eCTD format and IND-exempt bioavailability/bioequivalence (BA/BE) safety reports on Form FDA 3500A.
Regarding post-marketing safety reporting, the FDA has posted a guidance for the industry and a series of technical documents and specifications.
FDA E2B(R3) Core and Regional Data Elements and Business Rules (January 2023)
FDA ICSR XML Instances (January 2023)
However, post-market ICSRs are currently not being accepted in the E2B(R3) format and should continue to be submitted in the E2B(R2) format.
The FDA will update its website with further information on when the submission of safety reports in E2B(R3) format will be required and accepted on a voluntary basis. The industry is advised to follow the agency’s updates on FAERS and prepare accordingly for the electronic transmission of ICSRs
Find the official announcement here:
About Datafoundry
Datafoundry is a company with a vision to bring the power of AI/ML to Life Sciences and Healthcare industry for better health outcomes. We are a team of domain experts, data scientists and software developers building best-in-class AI models to deliver insights and process automation to key business processes to enable digital transformation of Life Sciences companies. Our current focus areas include Pharmacovigilance, Literature Research, Labelling, and Real-World Studies.
Contact:Priyanka Chakraborty