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Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Government publishes review of the Coronavirus Test Device Approvals (CTDA) process

On 29 December, the UK Health Security Agency published their statutory review of the CTDA process. The CTDA process was introduced to ensure that antigen and molecular Covid-19 tests were assessed for performance before being put into the UK market, intending to increase the quality of UK tests. The overarching theme of the review is summarised: “It is clear that…
Natalie Creaney
January 13, 2023
ConsultationsConsultations Archive

Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety

The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. They seek to improve the way they communicate with healthcare professionals. They want to hear from you to enable them to transform how they communicate with you and how they work together on your common goal of greater patient safety.…
Natalie Creaney
January 13, 2023
ConsultationsConsultations Archive

Consultation: Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes

NICE is producing guidance on using Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes in the NHS in England. The diagnostics advisory committee has considered the evidence and the views of non-company consultees and commentators, clinical experts and patient experts. You can now comment on the Appraisal Consultation Document (ACD). The advisory committee is interested…
Natalie Creaney
January 13, 2023
ConsultationsConsultations Archive

MRI fusion biopsy in people with suspected prostate cancer

NICE is producing guidance on using MRI Fusion biopsy in people with suspected prostate cancer in the NHS in England. The diagnostics advisory committee has considered the evidence and the views of clinical and patient experts. You can now comment on the diagnostics consultation document. It summarises the evidence and views that have been considered, and sets out the recommendations…
Natalie Creaney
January 13, 2023
Consultations

NHS Standard Contract 2023/24: A consultation

The NHS Standard Contract is published by NHS England for use by NHS commissioners to contract for all healthcare services other than primary care services. They are now consulting on changes for 2023/24 to both versions of the Contract – the full-length version, which is used to commission the bulk of such services by value, and the shorter-form version, which…
Natalie Creaney
January 13, 2023
HighlightsHighlights Archive

Media Monitoring: 7th – 13th January

Prostate cancer diagnosis ‘lottery’ sees regions lagging far behind London Scottish men are three times more likely to be diagnosed with prostate cancer late than men in London There is also a significant north-south divide, with all of the other poorest performing areas being outside of Southern England The figures, commissioned by Prostate Cancer UK, were gathered between 2014 –…
Natalie Creaney
January 13, 2023
HighlightsHighlights Archive

Industry experts appointed by Government to grow key sectors, including life sciences

Leading industry experts have been appointed by the Government to accelerate development and deployment of emerging tech in the UK, as Chancellor sets out vision to create the Silicon Valleys of the 21st century. The experts will work hand-in-hand with industry and Sir Patrick Vallance, the Government’s Chief Scientific Adviser and National Technology Adviser, to advise on new rules that…
Natalie Creaney
January 13, 2023
HighlightsHighlights Archive

Rapid NHS rollout sees 200,000 diabetes patients get life changing devices

Around eight in ten people with Type 1 diabetes now have access to life-changing technology, thanks to cost-effective deals secured for patients and rapidly rolled out by the NHS. Just over 200,000 patients are now using non-invasive glucose monitoring devices (CGMs) that allow people to check their glucose levels more easily and regularly – up by a third (around 50,000)…
Natalie Creaney
January 13, 2023