COVID-19: CDC, FDA and CMS Guidance
This page includes AHA Today stories and other AHA content on coronavirus COVID-19 guidance from the CDC, FDA, and CMS.
For the first time, the Food and Drug Administration authorized marketing a SARS-CoV-2 diagnostic test beyond the public health emergency based on additional data. FDA previously authorized the BioFire Respiratory Panel 2.1 test for emergency use to detect SARS-CoV-2 and other respiratory pathogens…
The Centers for Disease Control and Prevention has created a federal classification scheme for SARS-CoV-2 variants and posted information on their prevalence in the United States.
The Food and Drug Administration launched a dashboard that will provide weekly updates on adverse events submitted to its adverse event reporting system for COVID-19 drugs and biological products authorized for emergency use.
The Centers for Disease Control and Prevention allocated $10 billion to states and territories from the American Rescue Plan Act to support testing to screen teachers, staff and students for COVID-19 to help reopen schools.
The Food and Drug Administration alerted clinical laboratories staff and health care providers to the potential for positive results from a test made by Roche Molecular Systems to simultaneously detect and differentiate SARS-CoV-2 and influenza A/B.
The Centers for Medicare & Medicaid Services, in collaboration with the Centers for Disease Control and Prevention, issued updated visitation guidance for nursing homes, noting that more than 3 million COVID-19 vaccine doses have been administered to nursing home residents and staff.
The Food and Drug Administration issued an emergency use authorization for a next generation sequencing test to aid in identifying individuals with an adaptive T cell immune response indicating recent or prior infection with SARS-CoV-2.
The National Academy of Medicine has named an international committee to assess how COVID-19 vaccine development and other policies could facilitate global efforts to prepare for seasonal flu and a flu pandemic.
The Food and Drug Administration authorized the first molecular test to detect the SARS-CoV-2 virus in a nasal swab at home without a prescription. Cue Health expects by summer to daily produce more than 100,000 of the tests, authorized for use in patients age 2 and older.
The Centers for Disease Control and Prevention released interim guidelines for fully vaccinated individuals’ social practices. CDC said that those who are fully vaccinated — whether the two doses required by the Pfizer and Moderna vaccines, or the single Johnson & Johnson dose — may eschew…