Tag: FDA

Gallup poll finds disinterest in receiving COVID-19 vaccine

Editor's Note A Gallup poll of US adults conducted from July 20 to August 2 finds that 35% of those surveyed would not be interested in receiving a COVID-19 vaccine when one is approved by the Food & Drug Administration. The survey also finds that 41% of non-white Americans would…

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By: Judy Mathias
August 12, 2020
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FDA authorizes first COVID-19 diagnostic test for screening asymptomatic people

Editor's Note The Food and Drug Administration (FDA) on July 24 reissued its emergency use authorization (EUA) for LabCorp’s COVID-19 RT-PCR Test to include two new indications for use: Testing for individuals who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection. Allowing for pooled…

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By: Judy Mathias
July 28, 2020
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HHS taps Pfizer for large-scale COVID-19 vaccine production

Editor's Note The Department of Health and Human Services (HHS) and Department of Defense on July 22 announced an agreement with Pfizer to produce and deliver 100 million doses of its COVID-19 vaccine in the US, following manufacture and approval. Pfizer will deliver the doses, once the vaccine receives emergency…

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By: Judy Mathias
July 23, 2020
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Pfizer could have COVID-19 vaccine by October

Editor's Note Food & Drug Administration (FDA) approval of Pfizer’s COVID-19 vaccine could happen in October, the July 12 Time reports. The company was granted FDA Fast Track designation for the vaccine. Pfizer’s vaccine, being developed with its German biotech partner BioNTech, uses a messenger-RNA, genetics-based approach. Pfizer CEO Albert…

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By: Judy Mathias
July 15, 2020
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Late-stage COVID-19 vaccine trials to start this summer

Editor's Note The National Institute of Allergy and Infectious Diseases director Anthony Fauci says COVID-19 vaccine candidates will start moving into late-stage clinical trials by the end of July, continuing through the summer and into fall, the July 2 Reuters reports. The director of the National Institutes of Health, Dr…

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By: Judy Mathias
July 6, 2020
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FDA releases COVID-19 update

Editor's Note The Food and Drug Administration (FDA) on June 10 released a COVID-19 update announcing the following actions taken in its response to the pandemic: The FDA and National Institutes of Health have updated the CURE ID crowd-sourcing app to make it easier for healthcare providers to share their…

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By: Judy Mathias
June 11, 2020
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FDA reissues EUAs revising types of respirators that can be decontaminated

Editor's Note Citing a response to public health concerns, the Food & Drug Administration (FDA) on June 7 reissued certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination and reuse. The FDA determined that certain respirators should not be decontaminated for reuse by healthcare professionals during…

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By: Judy Mathias
June 9, 2020
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FDA accelerates development of COVID-19 prevention, treatment options

Editor's Note The Food & Drug Administration on May 11 took new actions to accelerate the development of novel prevention and treatment options for COVID-19. The agency is providing guidance documents to make the process for submitting applications to initiate studies for new drugs and biological products more efficient. The…

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By: Judy Mathias
May 14, 2020
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CMS releases proposed inpatient payment rule for FY 2021

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on May 11 released a proposed rule that increases Medicare inpatient prospective payment system (IPPS) rates by a net of 3.1% in FY 2021, compared to 2020, for acute care hospitals participating in the Hospital Inpatient Quality Reporting Program that…

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By: Judy Mathias
May 13, 2020
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OR leaders chart new territory for resuming elective surgery

Elective surgical procedures that were temporarily suspended in mid-March are now on the table—or soon will be—at some US facilities. The ban, announced on March 18 by the Centers for Medicare & Medicaid Services (CMS), was enacted to free up resources for facilities overwhelmed by surges of COVID-19 patients. On…

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By: Elizabeth Wood
May 12, 2020
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