Tag: FDA

Vaccine hesitancy and variants challenge efforts to tame COVID-19

The Janssen Biotech, Inc/Johnson & Johnson COVID-19 vaccine received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) on February 27, joining the Pfizer-BioNTech and Moderna vaccines that received EUA in December 2020. In early March, President Biden said that the US would produce enough COVID-19 vaccines…

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By: Elizabeth Wood
March 19, 2021
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COVID-19 cases, deaths, hospitalizations continue to fall

Editor's Note The number of new COVID-19 cases in the US dropped 12%, deaths fell 18%, and hospitalizations declined 16% last week, the March 8 Reuters reports. At the same time, an average of 2.2 million COVID-19 vaccines were administered each day, up from 1.6 million the week before. Despite…

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By: Judy Mathias
March 10, 2021
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FDA calls on 25 firms to stop displaying misleading certificates

Editor's Note The Food and Drug Administration (FDA) announced March 3 that it has asked 25 firms to stop producing and issuing misleading “FDA registration certificates” and FDA logos that create the impression the FDA has approved or authorized their products. The firms include mask, respirator, face shield, and other…

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By: Judy Mathias
March 4, 2021
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FDA: Class I recall of Medtronic's HVAD Pump Implant Kits

Editor's Note The Food and Drug Administration (FDA) on March 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as Class I, the most serious. The kit is part of the HeartWare HVAD System, which is used to help the heart pump blood…

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By: Judy Mathias
March 3, 2021
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FDA issues EUA for J&J’s single-dose COVID-19 vaccine

Editor's Note The Food and Drug Administration (FDA) on February 27 issued an emergency use authorization (EUA) for Johnson & Johnson’s single-dose COVID-19 vaccine, making it the third coronavirus vaccine approved for use in the US. The vaccine can be administered to people ages 18 and older. Vaccinations will begin…

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By: Judy Mathias
March 1, 2021
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Nearly 4M J&J vaccine doses to be delivered next week, if EUA granted

Editor's Note Up to 4 million doses of the Johnson & Johnson (J&J) single-dose COVID-19 vaccine will be delivered to states, community health centers, and pharmacies next week, if the vaccine receives Emergency Use Authorization (EUA) from the Food & Drug Administration (FDA), the February 24 The Hill reports. An…

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By: Judy Mathias
February 25, 2021
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FDA, USDA, CDC say COVID-19 can’t spread via food, packaging

Editor's Note The Food and Drug Administration (FDA), US Department of Agriculture (USDA), and Centers for Disease Control and Prevention (CDC), on February 18, issued a statement saying there is no epidemiological evidence out of more than 100 million cases globally that COVID-19 can be transmitted through food or food…

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By: Judy Mathias
February 23, 2021
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Diligence in implant processing will decrease infection risks

Implants are foreign bodies, and they increase the risk of a surgical site infection. Processing implants requires strict adherence to the required steps because implants have sustained contact with sterile tissue. An implant is defined as a device that is placed into a surgically or naturally formed cavity of the…

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By: Susan Klacik, BS, CRCST, ACE, CIS, FCS
February 17, 2021
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FDA issues EUA for monoclonal antibody treatments for COVID-19

Editor's Note The Food & Drug Administration, on February 9, issued an emergency use authorization (EUA) for Eli Lilly’s (Indianapolis, Indiana) combination therapy of two antibodies, bamlanivimab and etesevimab. The authorization is for the two antibodies to be administered together for treatment of mild to moderate COVID-19 in adults and…

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By: Judy Mathias
February 11, 2021
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FDA reduces N95 decontamination cycles from 20 to 4

Editor's Note The Food & Drug Administration (FDA), on January 22, lowered the number of times an N95 mask can be cleaned and reused to 4, down from a previous maximum of 20 reuses, the January 25 Fierce Biotec reports. The FDA reissued emergency use authorizations for 10 N95 decontamination…

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By: Judy Mathias
January 28, 2021
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