Blog

Oct 23, 2020
MHRA Guidance and regulatory flexibilities: Please see the regulatory flexibilities page for guidance for industry on flexible approaches to regulation we are taking during COVID-19.New or updated guidance published on their general guidance page for industry:Updated guidance:How tests and testing kits for COVID-19 workDetails of update:They have added a Target Product Profile for Laboratory-Based SARS-CoV-2 Viral Detection Tests.Updated guidance:Medical devices given exceptional use authorisati...
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Oct 23, 2020
Members can find the presentation slides and a copy of the Detection and Diagnosis Roadmap, discussed by CRUK in our recent External Affairs Working Party, attached. For any information please contact Cancer Research UK here.
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Oct 22, 2020
Stakeholders are invited to review the proposed approach to Updating the National Genomic Test Directory set out in the consultation document and provide feedback on the proposed approach to NHS England and NHS Improvement.Feedback is particularly invited on the following key topics:1) Appropriate involvement of patients and the public throughout the process;2) The proposed timelines for submission of applications; and3) Any potential impact the proposal may have on health equalitiesMembers can ...
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Oct 21, 2020
A UCL and LSE study has found that foreign direct investment (FDI) in the UK is to drop by 37% post-Brexit. This level is a 50% increase on previous estimates of the effect of Brexit on the investment levels of international companies in the UK economy. The peer-reviewed study, which is forthcoming in the Journal of Common Market Studies, highlights that the single market, since its implementation in 1992, has been the ‘cornerstone’ for additional foreign direct investment (FDI). As ...
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Oct 20, 2020
The government has published guidance on the minimum standards for private sector providers of COVID-19 testing.To request to be added to the indicative list of providers on GOV.UK, providers must declare that they meet these minimum standards by completing the form, as well as providing some additional information to support due diligence checks.The government envisages that UKAS (UK Accreditation Service) accreditation will become a minimum standard for all private sector p...
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Oct 19, 2020
A new tool has been developed in the United States which sheds light on COVID-19 testing equipment shortages through the supply chain. The online data collection tool has revealed the shortage of crucial supplies, including commercial testing kits needed for Covid-19 and other routine laboratory diagnostics. Microbiology laboratories in the USA have faced shortages of supplies, including COVID-19 test kits and reagents, since the beginning of the pandemic. As demand surges for COVID-19 testing, ...
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Oct 16, 2020
BIVDA EXPO 2020 - *** Online Venue Link has been Released!! *** Background & Purpose of the event:For our member companies during this difficult year, BIVDA is putting on a virtual Tradeshow with the intention for this to look and feel as close to the experience you would normally get with one of these events. Companies are being given a choice of shell scheme or floor space in 4 themed Halls. There will also be the chance to host live workshop webinars timetabled over the three days or...
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Oct 05, 2020
A new report composed by Professor Sir Mike Richards at the request of NHS Chief Executive Simon Stevens has put forward recommendations for diagnostic hubs at the community level for future diagnostic procedures. The report proposes the establishment of ‘one stop shops’ for diagnostics in the UK. These would be COVID-free zones, where a range of diagnostics could be carried out together to benefit patient health at the local level. In terms of location, free spaces in high streets o...
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Oct 02, 2020
Helen presented the COVID-19 Industry View next steps to the AMS round table. Speakers included Jo Martin, Neil Woodford, Jonathan Edgeworth, Sonia Gandhi, Dame Anna Dominiczak and me. This was a 5 minute presentation (attached to this page) but there was positive discussion and acceptance that moving forwards a triple helix between Industry, Academia and the NHS was key to delivering not only a testing strategy for Covid-19, but also linking in to the future strategy.
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Sep 30, 2020
Mr Mick Mulvaney, the US special envoy to Northern Ireland, has called for optimism on both sides over the push for a trade deal between the EU and United Kingdom. The US politician is currently on a trip to the UK and Ireland for a week, starting in Northern Ireland, followed by the Republic of Ireland and then London. The Republican politician was appointed to the post of special envoy in April of this year by President Donald Trump. Mr Mulvaney made the comments urging optimism shortly after ...
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