Lupus Foundation of America

FDA Revokes EUA For Chloroquine and Hydroxychloroquine

The United States Food and Drug Administration (FDA) has revoked their Emergency Use Authorization (EUA) for chloroquine and hydroxychloroquine for the treatment and prevention of COVID-19. The EUA ...
Nasdaq

Invivyd Submits Updated Immunobridging Analysis for Pemivibart to Support EUA Amendment for COVID-19 Treatment

Invivyd, Inc. announced the submission of an updated immunobridging analysis to the FDA, aimed at supporting an amendment to the Emergency Use Authorization (EUA) for its investigational monoclonal ...
National Academies of Sciences%2c Engineering%2c and Medicine

The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: A Workshop

Enacted in 2004, the EUA authority allows FDA to sanction on an expedited basis the sale of unapproved medical products for use in public health emergencies. The EUA has become critically important ...
Business Insider

Invivyd Provides Another Positive SARS-CoV-2 Variant Data Analysis to Satisfy U.S. FDA’s Gating Request for Completing Its Review of EUA Request for PEMGARDA™ (pemivibart ...

The EUA process does not rely on a statutory timeline such as the timelines embedded into the Prescription Drug User Fee Act (PDUFA)-based regulatory actions such as New Drug Application (NDA) or ...