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”
News
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?”
MHRA demonstrate flexibility in national application procedure with quick vaccine approval
A high dose Trivalent Influenza Vaccine was granted a UK licence within seven months, compared to the standard twelve month review time for national approvals. Read more “MHRA demonstrate flexibility in national application procedure with quick vaccine approval”
Are you aware that the ICH M9 guidance on BCS based bio-waivers will take effect in July?
The new guidelines provide recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS) based bio-waiver approach. Read more “Are you aware that the ICH M9 guidance on BCS based bio-waivers will take effect in July?”
UK government introduces post-Brexit medicines and medical device bill
In a post-Brexit overhaul, the UK government has introduced a human and veterinary medicines, clinical trials and medical devices bill, which could alter the regulatory framework at the end of the transition period. Read more “UK government introduces post-Brexit medicines and medical device bill”
Improving patient safety through integrated Yellow Card reporting
93% of GP practices in the UK will now be able to use their clinical IT system for integrated Yellow Card reporting of suspected adverse drug reactions (ADR) to the Medicines and Healthcare products Regulatory Agency (MHRA). Read more “Improving patient safety through integrated Yellow Card reporting”
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”
Would a Brexit deal hinder the UK medical device industry?
As the UK enters a transition period post-Brexit, there is evidence that a Brexit deal would require the medical device industry to abide by the EU Medical Device Regulation’s (MDR) tighter restrictions on development, thereby hindering the industry. Read more “Would a Brexit deal hinder the UK medical device industry?”
Brexit done: more information on the regulatory challenges that await
After years of waiting and wondering, the UK has finally left the EU. So, in the short term, how will the regulatory and drug safety environment change, and what will stay the same?
Read more “Brexit done: more information on the regulatory challenges that await”
China green-lights new reagent test kit for the novel coronavirus
A batch of nucleic acid reagent test kits have been approved with a medical device registration certificate, to help tackle the deadly novel coronavirus (2019-nCoV) outbreak. Read more “China green-lights new reagent test kit for the novel coronavirus”