Category: Regulations
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FDA Clears Rapid At-Home Covid-19 Test
The Food and Drug Administration granted an emergency authorization to a quick diagnostic test for SARS-CoV-2 viruses, conducted at home.
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Essay – Quick, Name the Secretary of HHS
Our country and world are in the worst health crisis in a century, and the U.S. cabinet secretary with the word “health” in the title is missing in action.
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Covid-19 Antibody Cocktail Trial Request Filed
A discoverer of synthetic antibodies is asking Food and Drug Administration for clearance to begin a clinical trial of a Covid-19 antibody cocktail therapy.
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Infographic – Unvaccinated Driving New Covid-19 Cases
Data released by the U.S. Centers for Disease Control and Prevention show new Covid-19 infections are concentrated largely among unvaccinated people.
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FDA Halts Off-the-Shelf T-Cell Cancer Trials
The Food and Drug Administration stopped a company’s clinical trials of off-the-shelf engineered T-cells after a patient showed an abnormal chromosomal reaction.
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FDA Okays One-Time HIV Treatment Clinical Trial
A company developing a one-time treatment for HIV infections using the gene-editing technique Crispr says it received FDA clearance to begin a clinical trial.
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Infographic – US Employer Vaccine Mandates Tick Up
A new poll shows a jump in the percentage of American workers now required by employers to get vaccinated against Covid-19.
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FDA Sends Warning on Covid-19 Food Therapy Trials
The Food and Drug Administration released yesterday a warning letter sent in late August to a company conducting clinical trials of a food therapy for Covid-19 symptoms.
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FDA Clears Stem Cell Trial for Multiple Sclerosis
The Food and Drug Administration has authorized a clinical trial of stem cells extracted and cultured from patients to treat their cases of multiple sclerosis.
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Micro Brain Robot Granted Orphan Status
A tiny remote-controlled device that carries chemotherapy drugs to brain tumors received orphan drug status from the Food and Drug Administration.