Tag: Food and Drug Administration

How one company is fast-tracking development of potential plasma-based treatments for the coronavirus

Medical biotech company Emergent BioSolutions is one of the many health industry players turning its efforts towards addressing the current global coronavirus pandemic. Their work includes a two-pronged effort to pursue plasma-based treatments that could help lessen the impact of COVID-19 on health care systems, with a fast-tracked development timeline…

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Non-profit aims to get COVID-19 field tests, N95 masks and more to healthcare workers without markups

A new Sydney-based non-profit volunteer organization called RapidWard launches this week, with a focus on getting critical medical supplies from producers in China to healthcare professionals, doctors, hospitals and governments worldwide who need them. The group, founded by serial entrepreneur and advisor Milton Zhou, has ample supply chain experience and…

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FDA updates COVID-19 testing guidelines to allow self-swab tests

The U.S. Food and Drug Administration (FDA) has updated its guidelines for COVID-19 testing procedures, in a bid to both make the process easier and less uncomfortable for patients, and to help limit the impact of testing on the supply of personal protective equipment (PPE) used by healthcare workers, including…

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Amazon Care to provide delivery and pick-up of at-home COVID-19 test sample kits in Seattle trial

Amazon is going to be working with a new research initiative backed in part by the Gates Foundation that will distribute at-home coronavirus assessment kits, and then deliver the collected samples to FDA-approved test facilities. Amazon Care, the health arm formed by Amazon initially for internal employee care, will be…

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Moderna could make experimental COVID-19 vaccine available to healthcare workers by fall

There are some hard limits to the vaccine development process that mean we are not going to see any preventative immune therapies to fight the new coronavirus for at least a year to 18 months. But Moderna, which is behind the first potential vaccine to enter human clinical trials in…

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Updated FDA COVID-19 testing guidelines specifically disallows at-home sample colllection

While a number of companies who currently offer at-home medical and health diagnostics had rushed to produce kits that would allow for self sample collection by people who passed a screening and believed they might have contracted the new coronavirus, the U.S. Food and Drug Administration (FDA) has updated its…

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