The proposal to relax regulation of genetically modified organisms (GMO) would allow GMO-containing COVID-19 candidate vaccines and therapeutics to proceed with clinical trials. Read more “European Commission proposes relaxation of GMO regulations”
Category: Trials
Highlights from the June 2020 ICMRA meeting on COVID-19
At the International Coalition of Medicines Regulatory Authorities (ICMRA) regular virtual meeting, high-level policy issues and regulatory approaches to ensure a co-ordinated response to the ongoing pandemic were discussed. Read more “Highlights from the June 2020 ICMRA meeting on COVID-19”
Major breakthrough as low-dose steroid found to reduce mortality in severely ill COVID-19 patients
A UK clinical trial has identified the low-dose, low-cost steroid dexamethasone as the first drug to improve survival rates in hospitalised COVID-19 patients with respiratory complications. Read more “Major breakthrough as low-dose steroid found to reduce mortality in severely ill COVID-19 patients”
IRB review of COVID-19 related expanded access requests
The US Food and Drug Administration (FDA) has released guidance, which provides clarification for institutional review boards (IRB) and clinical trial investigators, when reviewing individual patient expanded access requests related to COVID-19. Read more “IRB review of COVID-19 related expanded access requests”
Obtaining informed consent for clinical trials during COVID-19
The US Food and Drug Administration (FDA) have developed a new app which provides a suitable way of obtaining informed consent in an electronic format for both investigators and subjects. Read more “Obtaining informed consent for clinical trials during COVID-19”
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”
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?”
Exciting milestone for the MHRA’s CWoW Pilot
The Medicines and Healthcare products Regulatory Agency (MHRA) announced that 100 clinical trial applications have now been authorised via their Combined Ways of Working (CWoW) pilot scheme. Read more “Exciting milestone for the MHRA’s CWoW Pilot”
Clinical and in-vitro studies for potential drug-drug interactions
The US Food and Drug Administration (FDA) have finalised two guidances which provide recommendations to drug developers on how to evaluate drug-drug interactions (DDI) for investigational new drugs (IND), through in-vitro and clinical studies. Read more “Clinical and in-vitro studies for potential drug-drug interactions”