Category: Regulations
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Trial Requested for Covid-19 Vaccine Nasal Spray
Makers of a Covid-19 vaccine given as a nasal spray asked the Food and Drug Administration to authorize a a human clinical trial of the vaccine.
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FDA Grants Emergency Clearance for Home Covid-19 Test
The Food and Drug Administration gave an emergency authorization for a self-collected Covid-19 diagnostic test, the first such test for home use.
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ALS Stem Cell Therapy Fails to Meet Trial Objective
Clinical trial results of an amyotrophic lateral sclerosis, or ALS, therapy do not show slower disease progression among patients compared to a placebo.
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Infographic: U.S. Public Supports Lockdown
With Covid-19 cases in the U.S. accelerating in the past few weeks, a recent poll shows the public clearly favors a lockdown to stop the rise.
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Covid-19 Saliva Test Earns FDA Emergency Clearance
A test to detect Covid-19 viruses in saliva rather than nasal swabs received emergency authorization from Food and Drug Administration.
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FDA Issues Guidance to Boost Clinical Trial Diversity
Food and Drug Administration issued new regulatory guidance designed to enroll clinical trial participants more representative of the populations they claim to serve.
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Infographic – U.S. Public Split on Contact Tracing
While majorities of Americans say they’re willing to take part in contact tracing activities during the Covid-19 pandemic, large parts of the public are still reluctant.
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FDA to Use Lung Chip Model for Covid-19 Testing
The Food and Drug Administration plans to use organ-on-chip models to test mechanisms for preventing Covid-19 infections, and other processes.
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Lilly, NIH Halt Covid-19 Antibody Therapy Trial
Drug maker Eli Lilly and National Institutes of Health are stopping a clinical trial testing a synthetic antibody to treat hospitalized Covid-19 patients.
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Process Tests Thousands of Covid-19 Samples at Once
A new technology makes possible simultaneous analysis of diagnostic specimens from thousands of individuals revealing the presence of SARS-CoV-2 coronaviruses.