Points to consider when using real-world data in clinical studies
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MHRA announces proposals to improve access to world’s best medical devices for patients and to boost economic growth in Britain’s med tech sector
The MHRA has now published the government’s response to its public consultation on future routes to market for medical devices – designed to modernise regulation
If you take a GLP-1 medicine and have been hospitalised by acute pancreatitis, the Yellow Card Biobank wants to hear from you
GLP-1 medicines are licensed for Type 2 diabetes and weight management, and include the branded products Ozempic, Mounjaro and Wegovy
Cancel a medicine’s marketing authorisation or other licence
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Concizumab approved to prevent or reduce the frequency of bleeding episodes in people aged 12 years and older with haemophilia A or B with inhibitors
As with any medicine, the MHRA will keep the safety and effectiveness of concizumab under close review.
Guidance: Digital mental health technology: qualification and classification
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
Mirvetuximab soravtansine approved to treat adult patients who have ovarian, fallopian tube or primary peritoneal cancer
The approval is supported by a study involving 453 adults with advanced platinum-resistant cancers of the ovary, fallopian tubes and the peritoneum that were FRα positive