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FDA Issues Guidance for Clinical Trials during the COVID-19 Public Health Emergency
americanpharmaceuticalreview
June 30, 2020
The U.S. Food & Drug Administration (FDA) has issued a guidance for industry entitled, “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.”
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COVID-19 disruption of clinical trials starting to slow: GlobalData
expresspharma
June 18, 2020
FDA issued guidance recommends methods that could help keep the research going which includes virtual visits, phone interviews, self-administration, and remote monitoring.
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FDA Updates Q&A Appendix of Medical Products During COVID-19 Public Health Emergency
americanpharmaceuticalreview
June 09, 2020
The U.S. Food and Drug Administration (FDA) added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.”
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US approves Chinese drug maker Shanghai Green Valley’s Alzheimer’s therapy for large-scale clinical trials
SCMP
April 27, 2020
A Chinese drug maker has received approval from the Food and Drug Administration to start clinical trials in the US for a breakthrough Alzheimer’s drug as it seeks global validation for the controversial therapy.
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Nucleus Network's 10 Step Guide to conducting Clinical Trials during a time of uncertainty
prnasia
April 14, 2020
A new white paper, Undertaking Phase I Clinical Trials in Australia During a Time of Uncertainty, has been published by Nucleus Network (Nucleus), Australia's largest Phase 1 clinical trials provider.
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Sharp Supports Development of COVID-19 Vaccines and Treatments
contractpharma
April 08, 2020
Sharp Clinical, a provider of global clinical supply services, has confirmed that it is involved in supporting six clinical trials related to COVID-19.
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Pharmaseal Offers No Cost Support for COVID-19 Clinical Trials
contractpharma
April 06, 2020
Will offer the Engility clinical trials management system at no cost for COVID-19 coronavirus clinical trials.
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Sartorius Supports the Development of the First Vaccine Candidate Against the Novel Coronavirus to Enter Clinical Trials
.b3cnewswire
March 25, 2020
CanSinoBIO and the Institute of Bioengineering used Sartorius’ BIOSTAT® STR single-use bioreactor system for the upstream preparation of the recombinant vaccine, thus ensuring the rapid linear amplification of the adenovirus vector (Ad5-nCoV) and ultimate
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Feinstein Institutes begins three clinical trials for COVID-19 patients
pharmaceutical-business-review
March 24, 2020
Northwell Health’s Feinstein Institutes for Medical Research has announced the recruitment of patients in three clinical studies, which are designed to eliminate the COVID-19 novel coronavirus.
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Coronavirus (COVID-19) update: FDA issues guidance for conducting clinical trials
expresspharma
March 20, 2020
The US Food and Drug Administration has issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.