News In Brief
This article was originally published in The Silver Sheet
Executive Summary
FDA finally releases rule requiring electronic Medical Device Reporting; eReporting initiative for recalls struggles; and more.
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Adverse Event Reports Hit All-Time High; FDA Warns Firms About MDRs, Complaint Handling
As FDA sifts through almost a million Medical Device Reports submitted by manufacturers last year, the agency is trying to determine why so many adverse events are being reported. Isaac Chang, a director in CDRH’s Office of Surveillance and Biometrics, speculates that there could be a number of reasons for the large influx of MDRs, including high-profile recalls and a sharper FDA focus on human factors issues. Further, more than half of adverse events were reported to the agency on individual MedWatch forms in 2012 – a sharp increase over previous years. However, despite the extraordinary rise in reports, some firms continue to have trouble developing MDR procedures. Industry experts also weigh in on social media’s impact on adverse event reporting, and tips are shared for ensuring that complaints are properly handled by manufacturers.
Chinese Firms Up Their Game In Novel Flu Antiviral Development
Joincare Pharmaceutical and partner TaiGen Biotechnology tout preliminary Phase III results in uncomplicated acute influenza for TG-1000, a homegrown follower of Shionogi/Roche’s oral antiviral Xofluza. Novel antivirals for flu were hotly pursued by Chinese developers throughout 2023.
Quotable: Words Of Wisdom From Our Recent APAC Coverage
Scrip's APAC team selects notable quotes from recent interviews, conferences and other coverage to highlight the views of senior executives and officials on the major topics facing the biopharma sector in the region.