EU allows Pfizer/BioNTech COVID-19 vaccine to be stored at higher temperatures

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Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature.

Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures, with preferred storage set in an ultra-low temperature freezer between -80ºC to -60ºC.

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EU allows remote audits for medical devices during pandemic

The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively.

In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic has made in-person audits at manufacturers’ facilities difficult if not impossible.

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