by emma
24. October 2011 13:30
The EMA has started a new review of the cardiovascular safety of non-selective NSAIDS (non-steroidal anti-inflammatory drugs).
The CHMP’s previous opinion of NSAIDs in 2006 was positive, but a small possibility of an increased risk of thrombotic events such as heart attack or stroke could not be excluded, particularly involving high doses and long-term treatment with NSAIDs.
The CHMP will update its opinion in light of recently published evidence from the independent research project Safety Of non-Steroidal anti-inflammatory drugs (SOS) funded by the European Commission.
NSAIDS have been subject to several European reviews in relation to gastrointestinal and cardiovascular safety and the occurrence of serious skin reactions since the CHMP’s 2006 opinion.
It will review the results thoroughly, together with other available clinical research data, to distinguish the need to update the CHMP’s 2006 opinion.
d90071b1-7866-4baf-bfeb-bcac806dbfe4|0|.0
Tags: EMA, review, NSAIDs, non steroidal anti inflammatory drugs, CHMP, thrombotic events, heart attack, stroke, treatment, therapy, medicine, medication, drugs, pharma, pharmaceuticals, independent research, SOS, safety, gastrointestinal, cardiovascular, skin reactions, opinion, positive, 2006, clinical research
News
by emma
20. October 2011 12:25
NICE has appointed a new external assessment centre to support its Medical Technologies Evaluation Programme.
The new assessment centre, developed by Newcastle upon Tyne Hospitals NHS Foundation Trust Medical Physics Department in partnership with York Health Economics Consortium, will provide independent assessment of the clinical and health economic evidence for medical technologies.
It will also develop and facilitate independent research to assist suppliers when NICE guidance recommends that further research should be carried out on a medical device or diagnostic.
The new assessment centres were selected for their knowledge and expertise in the evaluation of medical technologies.
To date, one more external assessment centre, CEDAR – part of Cardiff and Vale University Local Health Board – has been commissioned.
Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said: “We’re delighted to welcome the new joint external assessment centre based at Newcastle and York. Their input to the production of NICE medical technology guidance will be essential, providing independent assessment of the evidence available for devices going through the NICE evaluation process.
“Where the relevant NICE advisory committee identifies that a technology has considerable potential but insufficient evidence to support widespread adoption across the NHS, it may make recommendations for further research. In such cases, the external assessment centre will play a key role in facilitating the development of further relevant evidence.
“We look forward to working with the centre, and benefitting from their combined technical and economics expertise in supporting the development of robust guidance for the NHS.”
Established by NICE in 2009, the Medical Technologies Evaluation Programme is focused specifically on innovative medical technologies. Seven NICE medical technology guidance documents have been published to date.
9c1dca2b-44dd-4b1a-87e8-219cc5bf4e1d|0|.0
Tags: NHS, UK, NICE, med tech, medtech, medical technology, assessment centre, appoint, Medical Technologies, Evaluation Programme, Tyne Hospitals, NHS Foundation Trust, York Health, independent research, guidance, medical device, diagnostic, CEDAR, Carole Longson, health technology, Newcastle, advisory committee, innovative medical technologies
Medtech News