USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports

Today (01 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, Oncology Center of Excellence released two final guidance "FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products" and "Providing Regulatory Submissions in Electronic Format: IND Safety Reports".

Guidance: FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products

This technical specifications guidance is intended to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA or Agency).

The following FDA-regulated products are described in this document: the technical approach to submitting ICSRs, incorporating its regionally controlled terminology, and adding FDA Adverse Event Reporting System (FAERS) data elements that aren't addressed in the International Conference on Harmonisation's (ICH) E2B (R3) Implementation Guideline (IG):

• Drug products marketed for human use with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs)

• Prescription drug products marketed for human use without an approved application

• Nonprescription (over-the-counter) drug products marketed for human use without an approved application

• Biological products with approved biologics license applications (BLAs).

Guidance: Providing Regulatory Submissions in Electronic Format: IND Safety Reports

The guidance explains the format for submitting IND safety reports to CDER and CBER electronically for serious and unexpected suspected adverse reactions, as required by 21 CFR 312.32(c)(1)(i).

The sponsor of an IND-approved clinical trial must report any serious or unexpected adverse reactions to FDA in an IND safety report within 7 to 15 days, depending on the severity of the incident. These reports have traditionally been submitted to FDA on MedWatch Form FDA 3500A or a Council for International Organizations of Medical Sciences I Form or other narrative forms.

This guidance applies to IND safety reports that are submitted to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). By following this guidance, sponsors must submit IND safety reports in accordance with FAERS to satisfy the electronic submission requirements.