Unexpected Clinical Trial Events: FDA Clarifies Sponsors’ Obligations To IRBs
This article was originally published in The Gray Sheet
Executive Summary
FDA guidelines issued Jan. 15 put the onus on device and drug trial sponsors to identify which adverse events that arise during clinical studies need to be reported to institutional review boards
You may also be interested in...
Clinical Trial Regs: FDA Seeks Advice On How To Make Them Better, Faster, Stronger
FDA is holding a two-day public hearing to get input on how to modernize its regulation of clinical trials; stakeholders cite need for innovative trial design, data sharing, guidance on use of biomarkers.
Regulatory News In Brief
Medtronic AED recall: Medtronic/Physio-Control is recalling certain Lifepak CR Plus automated external defibrillators that, in extremely humid environments, may improperly analyze a patient's heart rhythm and delay or fail to deliver therapy to patients in cardiac arrest. The Medtronic subsidiary began calling customers on Aug. 18 and sending replacement devices on Aug. 19. FDA classified the recall as Class I, the most serious category, on Sept. 16. Several Lifepak CR Plus devices were recalled in Aug. 2008 because of a software glitch (1"The Gray Sheet" Sept. 15, 2008)
Regulatory News In Brief
Medtronic AED recall: Medtronic/Physio-Control is recalling certain Lifepak CR Plus automated external defibrillators that, in extremely humid environments, may improperly analyze a patient's heart rhythm and delay or fail to deliver therapy to patients in cardiac arrest. The Medtronic subsidiary began calling customers on Aug. 18 and sending replacement devices on Aug. 19. FDA classified the recall as Class I, the most serious category, on Sept. 16. Several Lifepak CR Plus devices were recalled in Aug. 2008 because of a software glitch (1"The Gray Sheet" Sept. 15, 2008)