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”
Category: Product information
The latest updates on a variety of pharmaceutical products
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”
Highlights from the February CHMP meeting 2020
From their meeting in February, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the February CHMP meeting 2020”
The purple book
The US Food and Drug Administration (FDA) has launched its first searchable database of biological product information, called the Purple Book. Read more “The purple book”
Did you know that Bluetooth-related flaws are threatening hundreds of smart medical devices?
Smart medical devices, including medical tools, implants and pacemakers are being exposed to cyber-attack, due to vulnerabilities in their Bluetooth Low Energy (BLE) protocol. Read more “Did you know that Bluetooth-related flaws are threatening hundreds of smart medical devices?”
FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic
The Centres for Disease Control and Prevention’s (CDC) 2019-nCov Real-Time RT-PCR Diagnostic Panel has been approved for use across the US. Read more “FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic”
A harmonised approach to electronic product information (ePI)
In 2017, the European Commission (EC) identified electronic product information (ePI) as a means of improving how EU citizens access information about medicines. They have now released a set of principles to harmonise this approach. Read more “A harmonised approach to electronic product information (ePI)”
Highlights from the December CHMP meeting 2019
From their meeting in December, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the December CHMP meeting 2019”
The discovery of NDMA impurities in a common diabetes drug
Singapore’s Health Sciences Authority (HSA) has recalled three locally marketed metformin medicines after it was discovered that they contained N-nitrosodimethylamine (NDMA) impurities. Read more “The discovery of NDMA impurities in a common diabetes drug”
New “smart pill” technology shows 100% success rate
A new “smart pill” bottle which prompts patients to take their medications on time and notifies doctors when it has been dispensed, has shown 100% reliability in improving medication adherence. Read more “New “smart pill” technology shows 100% success rate”