3. Regulatory decision summary – Wegovy. Health Canadahttps://hpr-rps.hres.ca/reg-content/regulatory-decisionsummary-detail.php?lang=en&linkID=RDS00896(2022). 4. Wegovy summary of product characteristics. Medicines and Healthcare Products Regulatory Agencyhttps://mhraproducts4853.blob.core.windows...
Morgan, SarahVigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory AgencyMackay, AngusMedicines and Healthcare Products Regulatory Agency
(FDA)8, UK’s Medicines and Healthcare products Regulatory Agency (MHRA)9, Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, or the Federal Institute for Drugs and Medical Devices) and the EU Medical Devices Coordination Group (MDCG) have delineated where a “health app” ...
Today, with remote assessments, consumer wearables and digital health technologies, MRCs and patients are already collating substantial data sets that are relevant to quality-of-life benefits, regulatory and value assessments, all of great interest to biopharmaceutical companies. In turn, MRCs would ...
The regulation of CPMs and other TCMs is overseen by the Department of Pharmaceutical Affairs, Health Bureau [15]. At the moment, Macau does not have a registration system for CPMs. However, an alternative process is in place that takes reference of the regulatory decision made by the ...
These regulations are designed to ensure the safety and efficacy of veterinary products, protect animal health and welfare, and safeguard public health. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), oversee the approval and ...
Substantial interest and investment in clinical artificial intelligence (AI) research has not resulted in widespread translation to deployed AI solutions. Current attention has focused on bias and explainability in AI algorithm development, external validity and model generalisability, and lack of equity an...
Respiratory diseases, marked by structural changes in the airways and lung tissues, can lead to reduced respiratory function and, in severe cases, respiratory failure. The side effects of current treatments, such as hormone therapy, drugs, and radiothera
and effective public health control tool. As an outspoken defender of vaccines in the public square, I have become a major target. This has expanded significance because now the antivaccine movement has unprecedented levels of political power, organization, and financial support (Hotez2023a,b). ...
The rapidly evolving healthcare landscape has prompted Medical Affairs (MA) departments within pharmaceutical companies to transition from their traditional role as information providers to becoming strategic partners in the healthcare ecosystem. Responding to the increasing complexity of patient needs and st...