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, and equipment to treat respiratory failure.
Continue Reading April 16 Update: Key FDA Actions for COVID-19 Devices and Therapies
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 Upping Hospitals’ Liability Defenses For COVID Measures
Update: Key FDA Actions for COVID-19 Devices and Therapies
FDA is taking action every day to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, to support the development of therapeutics, and to facilitate remote patient access to healthcare providers. Recent key FDA developments include:
Continue Reading Update: Key FDA Actions for COVID-19 Devices and Therapies
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 multiple patient ventilation). FDA’s policies on permitting uncleared medical devices shift daily toward greater relaxation of regulatory hurdles for suppliers and manufacturers. The most recent policies on PPE importation and use in healthcare settings create more options for healthcare providers and patients in need of ventilatory support and help alleviate bottlenecks of necessary medical supplies in the supply chain.
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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 COVID-19 Combo Kit. Both tests are for the qualitative detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). FDA granted the authorizations within 24 hours of receiving the requests.
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. Companies with planned pre-approval inspections, however, may find the news distressing.
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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 on identifying and alleviating drug shortages before they happen. The FDA also is using emergency measures to provide access to diagnostic tests and other medicines that would not otherwise be available to the public.
Continue Reading How FDA is Reacting to the Coronavirus, and 2020 Regulatory Priorities