Category: Regulations
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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.
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FDA Bucks White House, Issues Strict Vaccine Guidance
The U.S. Food and Drug Administration yesterday issued guidance for Covid-19 vaccine developers, requiring extended follow-up with clinical trial participants.
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Int’l Lab Network to Assess Covid-19 Vaccines
Six clinical testing laboratories worldwide plan to evaluate vaccines for protecting against Covid-19 infections with a common set of test protocols.
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App Tracks Public Mask Wearing for Covid-19 Evidence
A mobile app is now available for individuals to count — NOT report — people wearing face masks, as an indicator of Covid-19 community infection spread.