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,...
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...
This article is part 1 of a mini-series focusing on the progression of global pandemics. This instalment explores the history of past pandemics and how they relate to the current COVID-19 situation. While it may seem that our current Covid self-quarantine has brought...
Staying at home for extended periods of time, also known as “cabin fever”, can feel like entrapment. Especially true for those accustomed to a hyper-connected lifestyle, quarantining can be detrimental to one’s well-being. Not being able to attend a dance...
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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