Drugs

October Deadline for New Adverse Event Reporting Standard

FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for submitting postmarketing safety reports, according to a notice scheduled for publication in the Federal Register.

The requirement applies to individual case safety reports (ICSRs) for human drugs, biologics and certain combination products submitted electronically to the agency’s Adverse Event Monitoring System (AEMS), the database formerly known as FAERS. Submissions made through the agency’s Electronic Submissions Gateway Next Generation (ESG NextGen) must use the International Council for Harmonization E2B(R3) format, a globally harmonized standard designed to improve the consistency and usability of safety data.

FDA officials said the updated format will enhance the quality of adverse event reporting and enable more efficient analysis. The E2B(R3) standard introduces expanded and revised data elements, evaluates seriousness at the individual event level rather than the overall case level, and allows attachments to be embedded directly within reports.

The transition marks the culmination of a multi-year shift toward international harmonization. FDA began accepting E2B(R3)-formatted submissions in 1/2024, allowing a two-year transition period during which companies could continue using the older E2B(R2) standard. Beginning 10/1, that transition period will end, and the agency said it intends to stop accepting ICSRs submitted in the legacy format.

Under existing regulations, pharmaceutical companies, biologics manufacturers and other responsible parties are required to submit postmarketing safety reports in an electronic format that FDA can process, review and archive. The updated standard is intended to align U.S. reporting requirements with international practices and improve pharmacovigilance capabilities.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

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