Drugs

Guidance on Case Safety Report eSubmissions

FDA has released a guidance entitled “FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products.” The document is intended to assist submitters in transmitting electronic individual case safety reports (ICSRs) and attachments to the FDA Adverse Event Reporting System (FAERS) database. The guidance describes FDA’s technical approach for submitting these, for incorporating its regionally controlled terminology, and for adding FAERS regional data elements that are not addressed in the guidance entitled “E2B(R3) Electronic Transmission of ICSRs Implementation Guide” for certain FDA-regulated products.

Additionally, the guidance describes the harmonized core set of ICH E2B(R3) data elements, ICH business rules, and other technical specifications for creating ICH-compliant XML files ICSR data exchange which were adopted by FDA. “Regional data elements are considered non-harmonized; however, the ICH XML file structure allows regions to use regionally controlled terminology and to add region-specific elements as outlined in this document,” the agency says.

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