Category: Regulations
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FDA Issues Covid-19 Therapy Trials, Review Guidance
The Food and Drug Administration issued new regulatory guidance on clinical trials and streamlined review processes for Covid-19 treatments.
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Infographic – U.S. Public Divided on Contact Tracking
A survey by the Washington Post and University of Maryland released this week indicates the proposed app is getting a lukewarm reception at best.
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Limited Covid-19 Benefits Found for Arthritis Drug
A clinical trial testing an arthritis drug to treat Covid-19 patients shows the drug helps the most critical patients, but not others with advanced infections.
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Trial Okayed in Germany for Covid-19 Vaccine
Regulators in Germany cleared a clinical trial to begin testing a vaccine with synthetic RNA to prevent coronaviruses from causing Covid-19 infections.
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BARDA Chief Removed for “Politics and Cronyism”
The director of the federal agency protecting against pandemics says he was removed for refusing to endorse President Trump’s preferred Covid-19 treatment.
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FDA Clears Home Covid-19 Diagnostic Test
The Food and Drug Administration today granted an emergency authorization for a Covid-19 diagnostic test performed at home and sent back to a lab.
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Covid-19 Saliva Sample Collection Cleared by FDA
A Covid-19 test procedure using saliva samples rather than specimens from the nose and throat received emergency clearance from the Food and Drug Administration.
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Univ. Lab to Offer Large-Scale Covid-19 Testing
A University of Maryland lab will seek FDA authorization for its plan to provide high-volume detection testing for Covid-19 infections among state citizens.
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Venture-Backed Start-Ups to Get Small Biz Loans
An industry group says rules for loans to small companies hard-hit by Covid-19 are changed to allow these loans for more start-ups funded by venture capital.
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Employers, Patients See Discounts from Biosimilars
An analysis of health care spending by large employers shows both companies and their employees are saving money from using non-branded biologic therapies.