- For Quick Launch:
The U.S. Meals and Drug Administration right this moment introduced the next actions taken in its ongoing response effort to the COVID-19 pandemic:
- On Might 17, the FDA offered abstract details about the standing of CytoDyn, Inc.’s growth program for the monoclonal antibody investigational drug, leronlimab, for the therapy of COVID-19. The info presently out there from current CytoDyn medical trials don’t assist the medical advantage of leronlimab for the therapy of COVID-19.
- The Janssen (Johnson & Johnson) COVID-19 Vaccine Truth Sheet for Recipients and Caregivers has been up to date and is offered in a number of languages.
- Testing updates:
- As of right this moment, 374 assessments and pattern assortment units are licensed by the FDA beneath emergency use authorizations (EUAs). These embrace 272 molecular assessments and pattern assortment units, 78 antibody and different immune response assessments, and 24 antigen assessments. There are 50 molecular authorizations and one antibody authorization that can be utilized with home-collected samples. There’s one molecular prescription at-home take a look at, two antigen prescription at-home assessments, 4 antigen over-the-counter (OTC) at-home assessments, and two molecular OTC at-home assessments.
- The FDA has licensed 9 antigen assessments and 4 molecular assessments for serial screening applications.
The FDA has additionally licensed 505 revisions to EUA authorizations.
The FDA, an company throughout the U.S. Division of Well being and Human Companies, protects the general public well being by assuring the security, effectiveness, and safety of human and veterinary medication, vaccines and different organic merchandise for human use, and medical units. The company is also chargeable for the security and safety of our nation’s meals provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.