Tower Mains Weekly Newsletter
New ISO Standard addresses Medical Device Labelling
A new ISO Standard on Medical Device Labelling has been published. ISO 20417:2021 provides the requirements for the identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information.
EMA initiates review of monoclonal antibody VIR-7831 for the early treatment of COVID-19
On 15th April 2021, GlaxoSmithKline and Vir Biotechnology announced that the European Medicines Agency (EMA) has initiated a review of VIR-7831, an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
FDA revokes EUA for Eli Lilly’s Covid-19 antibody therapy
On 16th April 2021, the US Food and Drug Administration (FDA) announced it had revoked the emergency use authorisation (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain paediatric patients.
EMA issues CVMP meeting highlights
On 16th April 2021, the EMA issued highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) meeting on the 13th-15th April 2021. Highlights include the referral procedure for modified live porcine respiratory and reproductive syndrome (PRRS) virus vaccines, and changes to the product information of Galliprant, Kexxtone, and Simparica Trio.
FDA issues COVID guidance on remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities
The FDA has issued guidance describing the various interactive and virtual tools used to conduct an evaluation at a facility. This guidance describes how remote interactive evaluations will be requested and conducted for the duration of the COVID-19 public health emergency at any facility where pharmaceutical products, including biological products, are manufactured, processed, packed, or held.
MHRA updates list of devices with exceptional use authorisations as well as those no longer covered
On 19th April 2021, the MHRA updated the list of manufacturers and devices granted exceptional use applications, as well as those recently expired, withdrawn, or cancelled.
COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
On 20th April 2021, the EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. The PRAC also concluded that these events should be listed as very rare side effects of the vaccine and confirmed the overall benefit-risk remains positive.
Clinical Trials Information System reaches major milestone towards go-live
On 21st April 2021, the EMA confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022.