FDA Revokes EUA for Bamlanivimab
On April 16, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when…
Regulations
FDA Plan For Reducing Exposure to Toxic Elements from Foods for Babies
Recently the Food and Drug Administration (FDA) releases an action plan for reducing exposure to toxic elements from foods for babies, young children. “Protecting one…
CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
On April 13, were released a joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine. “As of April 12, more than 6.8 million…
Two Revisions to Moderna COVID-19 Vaccine EUA
On April 1th, the U.S. Food and Drug Administration (FDA) announced two revisions regarding the number of doses per vial available for the Moderna COVID-19…
COVID-19 Vaccination at Dialysis Centers
A new federal effort announced on March 25, will help people with chronic kidney disease who require dialysis access COVID-19 vaccination at dialysis clinics, as…
FDA Warns Companies Illegally Selling CBD Products
The U.S. Food and Drug Administration (FDA) has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that…
Zealand Pharma Announces FDA Approval of Zegalogue (dasiglucagon)
Zealand Pharma announced on March 22, that the U.S. Food and Drug Administration (FDA) has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia…
Medicare Payment for COVID-19 Vaccination Increased
On March 15, the Centers for Medicare & Medicaid Services (CMS) is increasing the Medicare payment amount for administering the COVID-19 vaccine. “This new and…
FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test
On March 17, the U.S. Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), the first SARS-CoV-2 diagnostic test…
CDC Requirements For Airlines To Avoid Ebola Spread
Starting Thursday, March 4, 2021, airlines and other aircraft operators will be required to collect and transmit contact information to Centers for Disease Control and…