1. Medtech Insight
  2. >>Business
  3. >>R&D
  4. >>Clinical Trials

Aggregating Adverse Events Data Should Be Sponsor Responsibility: FDA

The US agency has published a draft guidance outlining investigator and sponsor responsibilities in which it says sponsors are better suited to report aggregated adverse events to regulators.

FDA entrance sign 2016

The US Food and Drug Administration says while it should be the responsibility of trial investigators to keep track of adverse events, it should be the sponsor’s responsibility to track aggregated events data and report it to regulators.

The agency on 29 September published the draft guidance “Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices,”...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Relief Cardiovascular Brings Relief To Heart Failure Patients With Smart Transcatheter Implant

 
• By Brian Bossetta

Successful implantations of a novel transcatheter mark a major step forward in treating congestion in heart failure, according to the California -based company that developed it. The procedure was part of a feasibility study evaluating the device’s safety.

‘Much-Needed Tool For Large Tissue Biopsy’: Resitu Medical’s Breast Device FDA Authorized

 
• By Natasha Barrow

Resitu Medical has received FDA 510(k) authorization for the RESL09 breast cancer biopsy device. This handheld minimally invasive device excises tissue samples with diameters up to 9 mm and will first reach market in the US. The company plans to expand the tool’s clinical claims and core size range.

Rapid Nexus Bets On Regeneration To Heal Wounds, Stop Amputations, Starting In VA Health Systems

 
• By Marion Webb

Rapid Nexus hopes its regenerative wound-healing system can ease the burden of diabetic foot ulcers and amputations. Backed by early clinical data and $3.8m in seed funding, the start-up is targeting the VA as a launchpad into a $6.5bn US market, with FDA clearance expected later this year.

MCED Act Advances In US House Committees, Exact Sciences Cancerguard Poised To Benefit

 
• By Natasha Barrow

The Nancy Gardner Sewell MCED Act has advanced in the US House, potentially allowing Medicare coverage for multi-cancer early detection tests. Exact Sciences is targeting FDA approval for its MCED test Cancerguard, launched in the US earlier this month.

More from R&D

Sava Technologies Microsensing Milestone: 10 Days Continuous Wear, No Finger-Prick Calibration

 
• By Natasha Barrow

Sava Technologies has developed a CGM that uses microneedles to accurately measure glucose levels for up to 10 days without finger-prick calibration. The company raised £14.2m in Series A funding to establish in-house manufacturing for faster production.

INBRAIN, Mayo Clinic To Test BCI With Standard Deep Brain Stimulation In Parkinson’s Patients

 
• By Marion Webb

Barcelona-based INBRAIN Neuroelectronics is partnering with Mayo Clinic to test whether its graphene-based cortical brain computer interface can enhance standard DBS in Parkinson’s, aiming for more precise adaptive therapy and improved gait outcomes.

New Guidelines Support Early Intervention With Edwards TAVR Device Sapien

 
• By Natasha Barrow

The new ESC and EACTS guidelines allow aortic stenosis patients without symptoms to be considered for a transcatheter aortic valve replacement. The move opens the market for Edwards Lifesciences, the only medtech with a Europe and US-approved device for asymptomatic severe aortic stenosis.