Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
On November 9, 2020, the U.S. Food and Drug Administration (FDA) released a final version of its guidance, Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs. ...more
In Tuesday's Report: the expanding role of real-world evidence in FDA medical device submissions; President-elect Joe Biden lays out COVID-19 plan; Pfizer announces vaccine efficacy; and an analysis of material adverse change...more
On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more
On June 16, the U.S. Food and Drug Administration (FDA) posted updates to their Molecular Diagnostic Templates for developers that intend their assay to be used for pooled patient samples or for screening asymptomatic...more
On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic."...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
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Biotechnology ,
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Clinical Trials ,
Coronavirus/COVID-19 ,
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Emergency Management Plans ,
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Good Clinical Practices ,
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Medicines and Healthcare Products Regulatory Agency (MHRA) ,
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Research and Development ,
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Trump Administration ,
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World Health Organization