The FDA announced today (5/1) that it would grant EUA for Gilead for their antiviral drug remdesivir for treatment in early response to suspected or confirmed patients with Covid. This authorization will allow the distribution of the drug all over the US, as well as...
The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on Friday (4/24) for medical devices in light of COVID-19. These guidances are used when demonstrating equivalence to existing devices,...
Yesterday, FDA Commissioner Scott Gottlieb made a statement on the new steps that the FDA is taking to improve innovation in medical devices. Like we have seen by authorities around the world, helping patients get more timely access to new innovations and medicines...
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