The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
- On July 29, FDA updated its “Food Safety and the Coronavirus Disease” webpage of Questions and Answers (Q&A). The Center for Food Safety and Nutrition added a new Q&A item, titled “What do U.S. exporters of FDA-regulated food products need to consider related to COVID-19?”
- On July 29, the FDA posted frequently asked questions for patients and consumers about antibody (serology) testing during the COVID-19 public health emergency. A COVID-19 antibody test, also known as a serology test, is a blood test that can detect if a person has antibodies to SARS-CoV-2, the virus that causes COVID-19. COVID-19 antibody tests can help identify people who may have been infected with the SARS-CoV-2 virus or have recovered from the COVID-19 infection.
- Today, the FDA updated its frequently asked questions on the Emergency Use Authorization for Remdesivir for Certain Hospitalized COVID-19 Patients. The update includes a question regarding changes to Gilead’s Fact Sheets for Health Care Providers and Patient and Parent/Caregivers. Gilead updated the fact sheets to incorporate the sponsor’s use of the proprietary name Veklury.
- Testing updates:
- To date, the FDA has currently authorized 193 tests under EUAs; these include 158 molecular tests, 33 antibody tests, and 2 antigen tests.
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