BIMO Tackles Clinical Trial Lapses With Training, Guidance, PMA Review Holds
This article was originally published in The Silver Sheet
Executive Summary
FDA’s DEVICE BIORESEARCH MONITORING PROGRAM is reinvigorating efforts to obtain compliance from clinical investigators and company sponsors charged with overseeing their conduct, following an alarming rise in violation rates. An online training course for clinical investigators is being prepared, a monitoring guidance for sponsors of clinical trials will be rewritten, and an inspection project to assess overall investigator compliance is underway. Meanwhile, FDA has initiated disqualification proceedings against three clinical investigators, and has halted premarket review of applications from three firms believed to have submitted unreliable data
You may also be interested in...
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.