Category Archives: AZBio News

AdvaMed Issues MedTech Compliance Guidance For COVID-19 Response

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WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today announced availability of a newly created “Code of Ethics Compliance Guidance Related to the COVID-19 Response.”

“This guidance seeks to help AdvaMed members and other medical technology companies develop and implement processes that both support rapid decision-making in the context of the pandemic and mitigate any related compliance risks,” said Christopher L. White, AdvaMed COVID action team leader, chief operating officer and general counsel.Continue reading→

What is the Bipartisan Commission on Biodefense?

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On January 20, 2019,  AZBio hosted a thought leadership event at Barrett-Jackson Scottsdale featuring a panel discussion on Health Innovation with Dr. Anna Barker and Dr. George Poste.   During the discussion, Dr. Poste, shared his thoughts on the need for governments and our industry to prepare for global pandemics and what the Bipartisan Commission on Biodefense had reported. Dr. Poste, an ex officio member of the commission, shared that is was not a matter of if a global pandemic would occur, but of when. 

The first report of a COVID-19 case in the U.S. was January 20, 2020.  Today, the world is learning more about what happens in a global pandemic than we ever wanted to know.  And, we still have a lot more to learn.Continue reading→

Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens

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The authorization is limited to testing performed at the Rutgers Clinical Genomics Laboratory using their molecular LDT COVID-19 authorized test for saliva specimens collected using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.  FDA states “It is important to note that this is not a general authorization for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home.”

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