MVG Insights In lieu of the COVID-19 outbreak, the FDA has issued 3 clinical guidances outlining new protocols related to the following: REMS requirements, alcohol-based sanitizer production, and the conduct of clinical trials of medical products. Each guidance resulted directly from the need for current protocol adaptation to address unmet needs due to COVID-19. 1. REMS […]
Industry News
FDA Issues New Guidances in Response to COVID-19.
April 16th, 2020 | Industry NewsCoronavirus Vaccine Clinical Trial Starting Without Usual Animal Data
March 13th, 2020 | Industry NewsInteresting read on the vaccine for COVID-19. While the speed at which Moderna has been able to progress their vaccine is impressive, it also raises many questions surrounding the bioethics of expediting such processes in the face of imminent need. Ethicists aren’t so sure that the eventual benefits of rushing this unproven vaccine into clinical […]