Newsletter - October 8, 2020
An EUA Fueled by Trump’s Treatment Sets Another Bad Precedence
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...Read More
FDA Celebrates Cybersecurity Month with New Clarifications on Policy
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...Read More
An EUA Fueled by Trump’s Treatment Sets Another Bad Precedence
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...Read More
FDA Celebrates Cybersecurity Month with New Clarifications on Policy
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...Read More
