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Robinson & Cole LLP

COVID-19 Testing — Additional Considerations

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At the start of the COVID-19 pandemic, each state and the federal government announced various states of public health emergencies which enabled them to suspend or modify various laws, rules, and regulations to accommodate...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Womble Bond Dickinson

A Promising Tool for Rapid Diagnosis of Unknown Infections in Body Fluids: Metagenomic Next-Generation Sequencing

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Scientists at the University of California-San Francisco (UCSF) have developed a single test, Metagenomic Next-Generation Sequencing (mNGS), that can rapidly identify infectious microbes in body fluids, increasing the speed...more

Husch Blackwell LLP

Missouri Encourages COVID-19 Diagnostic Testing But Urges Caution With Serological/Antibody Testing

Husch Blackwell LLP on

Due to expanded COVID-19 diagnostic testing availability, the Missouri Department of Health and Senior Services (MDHSS) is encouraging providers to test both symptomatic and asymptomatic individuals, if the clinician’s...more

McGuireWoods LLP

FDA’s Emergency Use Authorization Process for COVID-19 Tests May Alleviate Shortage

McGuireWoods LLP on

As the nation battles shortages of novel coronavirus (COVID-19) testing kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency use authorizations (EUA) process for unapproved products and uses to...more

Bricker Graydon LLP

COVID-19 Update: FDA announces policies to increase availability of coronavirus testing

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The Food and Drug Administration (FDA) announced a policy shift on March 16, 2020, to allow state health departments to approve COVID-19 (coronavirus) diagnostic tests without FDA involvement during the current public health...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

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The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

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