The FDA announced that it would strengthen its oversight for companies marketing the Covid serology tests. After questions came to light in regards to the accuracy of some of the testing kits, the FDA is now requiring commercial manufacturers to submit an emergency...
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...
There has been amazing cooperation by companies with global supply chains to come together during Covid and produce surplus PPE and ventilators for domestic and international markets. Communicating effectively across multi-lingual global supply chains is more...
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,...
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