Category Archives: Coronavirus

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Not So Fast – FDA Retracts Authorization for Some Respirators Made in China

Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational … Continue Reading

FDA Updates Policy to Curb Unreliable COVID-19 Antibody Tests

On May 4, 2020, the US Food and Drug Administration (FDA) updated its enforcement policy on antibody tests for COVID-19.  The revised policy requires developers of commercial antibody tests to submit a request for emergency use authorization (EUA) to FDA.  Under the previous policy, commercial test developers could distribute their tests without FDA authorization.  The … Continue Reading

April 16 Update: Key FDA Actions for COVID-19 Devices and Therapies

As reported earlier here, FDA is taking steps to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, support the development of therapeutics, and facilitate remote patient access to healthcare providers. Key FDA regulatory developments since our last update include new Emergency Use Authorizations (EUAs) for face shields, N95 respirator decontamination systems, … Continue Reading

Upping Hospitals’ Liability Defenses For COVID Measures

This article originally appeared in Law360 on April 13. The Public Readiness and Emergency Preparedness Act, along with the declaration by the U.S. Department of Health and Human Services on countermeasures against COVID-19, provide hospital systems with broad liability protections for measures taken in response to the pandemic.… Continue Reading

Personal Protective Equipment & Ventilators: How FDA Is Increasing Supply for the US Healthcare System

In light of the widely reported shortage of personal protective equipment (PPE), ventilators, other medical devices, the U.S. Food and Drug Administration (FDA) is working around the clock to authorize medical supplies for the US healthcare system, including relaxing its rules for importing and distributing PPE and ventilators and their accessories (e.g., vent splitters for … Continue Reading

FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19

The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week.  The first authorization was issued to Roche Molecular Systems, Inc., for its cobas SARS-CoV-2 Test, and the second issued the following day to Thermo Fisher Scientific, Inc., for its TaqPath … Continue Reading

FDA Postpones Ex-US Facility Inspections

U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak.  Manufacturers, including contract manufacturers, anticipating post-approval inspections may welcome the news, given other pressing issues facing ex-US facilities (i.e., facilities located outside the US) in light of COVID-19.  … Continue Reading

How FDA is Reacting to the Coronavirus, and 2020 Regulatory Priorities

The nation’s reaction to the Coronavirus Disease (COVID-19) has been fierce—maybe unprecedented.  Information so far suggests that most COVID-19 illness is mild, yet the reaction from global markets has been drastic.  The US Food and Drug Administration (FDA) is closely monitoring the impact of the Coronavirus on the global drug supply chain and is focused … Continue Reading
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