Devices

3 ICSR Electronic Transmission Guidances

FDA has published three guidances relating to implementing a standard adopted by the International Council for Harmonization (ICH) for electronic transmission of individual case safety reports (ICSRs). The first guidance, E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide—Data Elements and Message Specification, focuses on technical implementation for medicinal products and therapeutic biologics for human use. The document says its business objective is to standardize the definitions of the data elements used in the electronic transmission of different types of ICSRs, regardless of source and destination.

The second guidance, Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide—Backwards and Forwards Capability, is intended to assist reporters and recipients (including pharmaceutical companies, authorities, and non-commercial sponsors) in implementing systems with special focus on the recommendations for conversion back and forth between the previous standard and this standard.

The third guidance, FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products, is intended to assist submitters in transmitting electronic ICSRs and their attachments to the FDA Adverse Event Reporting System (FAERS) database. The document describes the agency’s technical approach for submitting ICSRs, incorporating its regionally controlled terminology, and for adding FAERS regional data elements that are not addressed in the ICH implementation guide.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome