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...
Yesterday (4/30) the FDA lifted some of the security requirements in the Drug Supply Chain Security Act to help expedite adequate distribution of prescription drugs due to COVID-19. These exemptions and exclusions apply to...
The FDA released guidance on Tuesday (4/28) for bioequivalence studies intended for submission in Abbreviated New Drug Applications (ANDAs). Due to Covid, many clinical trial studies have been negatively impacted due to travel limitations, site closures, etc. With...
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,...
In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also...
Yesterday (4/21) the FDA announced EUA for at-home Covid testing kits from LabCorp. These nasal swab tests were previously authorized in mid-March by the FDA, however only for medical professionals to use. Stephen Hahn, FDA Commissioner, released in a statement that...
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