01/29/2020 12:00 AM EST
Source: World Health Organization (WHO). Published: 1/29/2020. This 60-page protocol has been designed to investigate the First Few X (FFX) cases of 2019 novel coronavirus (2019-nCoV) and their close contacts. It is envisioned that the FFX 2019-nCoV investigation will be conducted across several countries or sites with geographical and demographic diversity. Using a standardized protocol such as the protocol provided here, epidemiological exposure data and biological samples can be systematically collected and shared rapidly in a format that can be easily aggregated, tabulated, and analyzed across many different settings globally for timely estimates of 2019-nCoV infection severity and transmissibility, as well as to inform public health responses and policy decisions. (PDF)
01/28/2020 12:00 AM EST
Source: Nuffield Council on Bioethics. Published: 1/28/2020. This 308-page report provides the findings of a two-year in-depth inquiry into the ethical issues relating to research in global health emergencies. The aim of the report is to identify ways in which research can be undertaken ethically during emergencies, in order to promote the contribution that ethically conducted research can make to improving current and future emergency preparedness and response. The report makes 24 recommendations. (PDF)
01/25/2020 12:00 AM EST
Source: World Health Organization (WHO). Published: 1/25/2020. This 12-page case record form (CRF) for 2019 the novel coronavirus is intended to provide member states with a standardized approach to collect clinical data in order to better understand the natural history of disease and describe clinical phenotypes and treatment interventions (i.e., clinical characterization). By using one standardized clinical data tool, there is potential for clinical data from around the world to be aggregated, in order to learn more to inform the public health response and prepare for large-scale clinical trials. (PDF)
01/09/2020 12:00 AM EST
Source: European Union, European Centre for Disease Prevention and Control (ECDC). Published: 1/9/2020. This three-page threat assessment details options for response and safety precautions regarding the novel coronavirus and associated pneumonia cases that have been reported in Wuhan, China. It discusses a risk assessment for the European Union/European Economic Area (EU/EEA), including the risk for travelers, introduction, and further spread in the EU. (PDF)
04/29/2019 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 4/29/2019. To help prepare for potential and current emergencies, the Food and Drug Administration (FDA) works with medical countermeasure developers to prepare Pre-Emergency Use Authorization (Pre-EUA) packages, when appropriate. This web page provides information about how medical countermeasure developers can submit a Pre-EUA for an in vitro diagnostics (IVD) test for a pathogen with a current EUA declaration, and for a pathogen that does not have a current EUA declaration. (Text)
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