FDA began accepting IND Safety Reports in E2B format, November 21.
In preparation for the receipt of IND Safety Reports, FDA has posted the following documents regarding the electronic submission of certain investigational new drug applications (INDs) safety reports for drugs and biological products to FAERS. These documents are posted to help prepare systems for electronic submissions of IND safety reports.
- Providing Regulatory Submissions in Electronic Format: IND Safety Reports – Draft Guidance for Industry (October 2019)
- Electronic Submission of IND Safety Reports – Technical Conformance Guide (October 2019)
- The revised technical specifications document Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments (April 2021). FDA has revised this document to include data elements, descriptors, and descriptor values for reporting certain IND safety reports as individual case safety reports (ICSRs).
For investigational drugs and biological products without an established name (i.e. INN or USAN name), or if the established name exceeds established E2B character lengths, prior to submission of IND safety reports to FAERS, the sponsor should submit to the IND a general correspondence in eCTD format to inform FDA of how the product name will be submitted within the established E2B character lengths. Please refer to the Electronic Submission of IND Safety Reports – Technical Conformance Guide (October 2019) for further information.
Postmarketing Safety Reporting
FDA has modernized the FDA Adverse Event Reporting System (FAERS). The new system went live on November 10, 2021. Data elements Message Number (M.1.4 <messagenumb>) must be unique for each M.1.5 <messagesenderidentifier> which will make the combination of <messagenumb> and <messagesenderidentifier> distinct per submission in order to receive a positive acknowledgement from FAERS. Please continue to submit postmarketing safety reports using the current DTD 2.1 or DTD 2.2.