The European Medicines Agency (EMA) have nominated Emer Cooke as their new Executive Director. Read more “Did you know that the EMA have a new Executive Director?”
News
Highlights from the June CHMP meeting 2020
From their meeting in June, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the June CHMP meeting 2020”
Recommendations to help reduce the risk of impurities in medicines
European regulators have proposed 40 recommendations to help reduce the risk of impurities in medicines, and to ensure that regulators are better prepared to manage cases of unexpected impurities. Read more “Recommendations to help reduce the risk of impurities in medicines”
European Commission proposes relaxation of GMO regulations
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”
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”
FDA releases policy for ANDA conversion after patent infringement
What is the US Food and Drug Administration (FDA) procedure for the conversion of an abbreviated new drug application (ANDA) status from final to tentative approval, following a court order for patent infringement? Read more “FDA releases policy for ANDA conversion after patent infringement”
Transitioning devices with ancillary substances to MDR
A guidance recently published by the Medical Device Coordination Group (MDCG) explains the process for transitioning CE certificates for devices containing an ancillary substance under the Medical Device Regulation (MDR). Read more “Transitioning devices with ancillary substances to MDR”
The latest update on the MDR, IVDR implementation timeline
The European Commission (EC) has updated its rolling plan for adopting implementing acts ahead of the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). Read more “The latest update on the MDR, IVDR implementation timeline”
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”