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FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

COVID-19 Update: FDA Authorizes First At-home Collection Kit

FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s...more

FDA Working To Address 2019 Novel Coronavirus: Diagnosis & Treatment (Part III)

FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and...more

FDA Working To Address 2019 Novel Coronavirus: Supply Chain (Part II)

FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and...more

FDA Working To Address 2019 Novel Coronavirus: Product Safety (Part I)

FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and...more

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