The European Commission (EC) has asked EU law makers to delay the implementation of the incoming Medical Device Regulation (MDR), which is due to apply from 26 May 2020. Read more “European Commission pursues one year delay to MDR”
News
CPAP device gains rapid MHRA approval for use in COVID-19
A Continuous Positive Airway Pressure (CPAP) device, which can help to keep coronavirus patients out of intensive care, has been created in under a week, and gained rapid approval by the Medicines and Healthcare products Regulatory Agency (MHRA). Read more “CPAP device gains rapid MHRA approval for use in COVID-19”
Expanding the availability of critical ventilator devices to fight COVID-19
With an urgent need for the rapid manufacture of life-saving ventilator systems for hospitals to fight the current pandemic, the Medicines and Healthcare products Regulatory Agency (MHRA), along with their international counterparts, have outlined how they intend to expand the availability of such devices. Read more “Expanding the availability of critical ventilator devices to fight COVID-19”
FDA guidance on adverse event reporting during a pandemic
The US Food and Drug Administration (FDA) have published an updated guidance on post-marketing adverse event reporting for medical products and dietary supplements during a pandemic. Read more “FDA guidance on adverse event reporting during a pandemic”
Further information on how to manage clinical trials during the pandemic
The Medicines and Healthcare products Regulatory Agency (MHRA) have now released guidance on how investigators and sponsors should manage clinical trials during COVID-19. Read more “Further information on how to manage clinical trials during the pandemic”
MDCG rolls out host of new guidances and updates with MDR looming
With 26th May fast approaching, the Medical Device Co-ordination Group (MDCG) has published three new guidances, two updated guidances and an implementation/preparedness plan for the incoming Medical Device Regulation (MDR). Read more “MDCG rolls out host of new guidances and updates with MDR looming”
The first in-human trial for a coronavirus vaccine!
The first dose of a potential coronavirus vaccine has been administered to a clinical trial participant in the US. Read more “The first in-human trial for a coronavirus vaccine!”
How will coronavirus affect the management of clinical trials in the UK?
The Medicines and Healthcare Regulatory Agency (MHRA) have offered advice on the management of clinical trials during the coronavirus outbreak in the UK. Read more “How will coronavirus affect the management of clinical trials in the UK?”
COVID-19: Asia-Pacific Regulatory roundup
Catch up with the latest COVID-19 related regulatory interventions in the Asia-Pacific region. Read more “COVID-19: Asia-Pacific Regulatory roundup”
A potential plasma-derived therapy for COVID-19
Development has been initiated for an anti-SARS-CoV-2 polyclonal hyper-immune globulin (H-IG) to treat high-risk individuals with COVID-19. Read more “A potential plasma-derived therapy for COVID-19”