Industry News

FDA Issues New Guidances in Response to COVID-19.

April 16th, 2020 | Industry News

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 […]

Coronavirus Vaccine Clinical Trial Starting Without Usual Animal Data

March 13th, 2020 | Industry News

Interesting 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 […]

FDA Grants Breakthrough for Lupus Nephritis

October 14th, 2019 | Industry News

Exciting news for Lupus Nephritis from the FDA. Discover the latest news about our company, our products, our policies, and our people. Source: Genentech: Press Releases | Tuesday, Sep 17, 2019