Articles Tagged With: FDA
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N95s Moving Back to Single Use, Phasing Out Reprocessing
Hospitals should begin phasing out reprocessing systems for single-use N95 respirators, as national supplies have been replenished and it is time to end the temporary crisis response to the pandemic, the Food and Drug Administration stated in a letter to the healthcare industry. -
Proactive Programs Needed to Address Vaccine Resistance
Even as millions of Americans continue to receive the COVID-19 vaccine, some healthcare organizations still struggle with a worrying number of employees who will not accept the vaccines. Physicians and other leaders should address concerned employees and correct misinformation. -
FDA Lifts Restriction on Mifepristone Access
Federal rule had required women to pick up the drug in person only, even during the COVID-19 pandemic.
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United Kingdom Begins First COVID-19 Human Challenge Study
Lawmakers, academics, and the research community have hotly debated the ethics of a human challenge study since the first months of the COVID-19 pandemic. Now that the United Kingdom has started dosing patients in its human challenge study, some bioethicists say this trial can show vaccine efficacy in ways the larger vaccine trials cannot.
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A Third Arrow in the Quiver: FDA Grants Emergency Use of New Vaccine
The Food and Drug Administration has issued an emergency use authorization for a third vaccine COVID-19 in the United States, approving Janssen Biotech’s vaccine for administration to those 18 years and older.
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FDA, CDC Sign Off on Third COVID-19 Vaccine
Johnson & Johnson’s COVID-19 vaccine is the first single-shot solution to receive an agency emergency use authorization.
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One Dose, Lower Temps May Suffice for Pfizer/BioNTech COVID-19 Vaccine
Encouraging new data emerge regarding storage, administration requirements.
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Evolving Ethics of ‘Right to Try’ Unproven Drugs
Ethical concerns persist regarding seriously ill patients who want the chance to try unproven, unapproved drugs.
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Bamlanivimab Injection
Bamlanivimab is a neutralizing recombinant IgG1 monoclonal antibody that connects to the receptor-binding domain of the spike protein of SARS-CoV-2. The drug blocks attachment and entry of the virus into human cells.
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FDA Issues Third COVID-19 Therapeutic EUA This Month
The list of COVID-19 therapeutics is growing rapidly.