Regulating drugs, medical devices, and diagnostic tests in the European Union: early lessons from the COVID-19 pandemic?

Fraser, Alan G; Szymanski, Piotr; Macintyre, Elizabeth; Landray, Martin

Fraser, Alan G; Szymanski, Piotr; Macintyre, Elizabeth; Landray, Martin.

Fraser AG; Department of Cardiology, University Hospital of Wales, Cardiff, UK.
Szymanski P; Cardiovascular Imaging and Dynamics, Katholieke Universiteit Leuven Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium.
Macintyre E; Centre of Postgraduate Medical Education, MSWiA Central Clinical Hospital, ul. Woloska 137, 02-507 Warsaw, Poland.
Landray M; Hématologie Biologique and INSERM UMR1151, Université de Paris (Descartes), Hôpital Necker Enfants Malades, 149 rue de Sèvres, Paris 75743, France.

Eur Heart J ; 41(23): 2140-2144, 2020 06 14.

Article in English | MEDLINE | ID: covidwho-601090

Subject(s)

Coronavirus Infections/diagnosis; Coronavirus Infections/therapy; Device Approval; Diagnostic Test Approval; Drug Approval; European Union; Pneumonia, Viral/diagnosis; Pneumonia, Viral/therapy; Anti-Bacterial Agents; Antibodies, Monoclonal, Humanized/therapeutic use; Anticoagulants/therapeutic use; Antimalarials/therapeutic use; Antiviral Agents/therapeutic use; Azithromycin/therapeutic use; Betacoronavirus; Biomedical Research; COVID-19; COVID-19 Testing; Clinical Laboratory Techniques/standards; Coronavirus Infections/drug therapy; Coronavirus Infections/epidemiology; Data Accuracy; Drug and Narcotic Control; Glucocorticoids/therapeutic use; Heparin/therapeutic use; Humans; Immunization, Passive/standards; Medical Device Legislation; Pandemics; Personal Protective Equipment/standards; Pneumonia, Viral/epidemiology; SARS-CoV-2; Ventilators, Mechanical/standards; COVID-19 Drug Treatment; COVID-19 Serotherapy

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Drug Approval / Coronavirus Infections / Device Approval / European Union / Diagnostic Test Approval Type of study: Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: Eur Heart J Year: 2020 Document Type: Article Affiliation country: Eurheartj

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