Day: October 8, 2020

October is the national cybersecurity awareness month and to celebrate it, FDA updated its cybersecurity webpage and created a new Factsheet to dispel several misperceptions about FDA’s role in assuring cybersecurity measure in medical devices. Over the last decade, as networked devices play a significantly larger role in overall health management, and in medical devices, … Read more

Regeneron filed for an EUA for its antibody cocktail for COVID-19 within days of it being used to treat President Trump. While emergency use authorizations based on data from a few patients are not uncommon, the timing of this application and the immediate public authorization by the President creates an impression that Regeneron is trying … Read more