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May 26, 2020 - Coronavirus (COVID-19), FDA, Drug & Medical Device, Product Liability, Emergency Use Authorization (EUA)
FDA Signals Flexibility with COVID-19 Tests
By: Erin M. Bosman and Julie Y. Park
A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps
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May 08, 2020 - Coronavirus (COVID-19), FDA, Emergency Use Authorization (EUA)
COVID-19 Alert: FDA Updates Antibody Test Policy
By: Erin M. Bosman and Julie Y. Park
Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been
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May 01, 2020 - Coronavirus (COVID-19), FDA, Emergency Use Authorization (EUA)
COVID-19 Update: FDA Authorizes First At-Home Collection Kit
By: Erin M. Bosman and Julie Y. Park
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 around-the-clock work since this outbreak began has resulted in the authorization of more
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April 30, 2020 - Coronavirus (COVID-19), FDA, Pharmaceutical & Medical Devices
Mental Health During COVID-19: FDA Waivers for Digital Health Devices
By: Jean Nguyen Ph.D.
As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern. Last week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for treating
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April 22, 2020 - Coronavirus (COVID-19), FDA, Pharmaceutical & Medical Devices, Emergency Use Authorization (EUA)
FDA Uses EUAs Broadly in the Fight Against COVID-19
By: Julie Y. Park
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel
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April 21, 2020 - Coronavirus (COVID-19), FDA, Emergency Use Authorization (EUA)
HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation
By: Erin M. Bosman and Julie Y. Park
On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19. The PREP Act grants tort
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April 09, 2020 - Coronavirus (COVID-19), FDA, Product Liability, Pharmaceutical & Medical Devices
CARES Act of 2020: Guide for Drug and Device Companies
The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward. The
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March 30, 2020 - Coronavirus (COVID-19), FDA, Pharmaceutical & Medical Devices, Emergency Use Authorization (EUA)
FDA Inspires Modifications and Quick Authorizations for Ventilators
By: Erin M. Bosman and Julie Y. Park
As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators. Ventilator Modification Enforcement
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March 27, 2020 - Coronavirus (COVID-19), FDA, Consumer Products, Emergency Use Authorization (EUA)
FDA Warns Against At-Home COVID-19 Testing Kits
By: Erin M. Bosman and Julie Y. Park
A number of startups announced they would begin selling at-home COVID-19 testing kits this week. These startups included: Carbon Health, a tech-enabled healthcare network that combines virtual and in-person care, Everlywell, a company that offers food sensitivity and various other home health tests, and
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March 24, 2020 - Coronavirus (COVID-19), FDA, Pharmaceutical & Medical Devices
FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked
By: Erin M. Bosman and Julie Y. Park
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based
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Topic Archives: FDA

FDA Signals Flexibility with COVID-19 Tests

By: Erin M. Bosman and Julie Y. Park

COVID-19 Alert: FDA Updates Antibody Test Policy

By: Erin M. Bosman and Julie Y. Park

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

By: Erin M. Bosman and Julie Y. Park

Mental Health During COVID-19: FDA Waivers for Digital Health Devices

By: Jean Nguyen Ph.D.

FDA Uses EUAs Broadly in the Fight Against COVID-19

By: Julie Y. Park

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

By: Erin M. Bosman and Julie Y. Park

CARES Act of 2020: Guide for Drug and Device Companies

FDA Inspires Modifications and Quick Authorizations for Ventilators

By: Erin M. Bosman and Julie Y. Park

FDA Warns Against At-Home COVID-19 Testing Kits

By: Erin M. Bosman and Julie Y. Park

FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked

By: Erin M. Bosman and Julie Y. Park