Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
What Health Care Providers and Facilities Should Know About the PREP Act's "Covered Countermeasures"
COVID-19 Hospice How-To Series: The Latest on Testing and Vaccinating Employees
On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued another groundbreaking amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). ...more
As the COVID-19 pandemic continues, and with an incoming Biden administration that is expected to step up efforts to control the spread of the virus, use of personal protective equipment (“PPE”) and cleaning/disinfectant...more
The FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically,...more
When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and...more
A New Jersey District Court Judge has ruled that the March 2020 federal liability immunity statute for pandemic-related countermeasures does not create a basis for federal jurisdiction, resulting in the remand of two...more
Businesses await clarity from the federal government on liability protections for injuries resulting from COVID-19. Current federal law provides liability protection to businesses but is limited to COVID-19 related...more
The US Food and Drug Administration (FDA) has been developing and shifting its guidelines for Personal Protective Equipment, or PPE, during COVID-19. The Agency has articulated its guidelines for PPE in one of two ways: (1)...more
On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Medical...more
On January 31, 2020, the Secretary of the United States Department of Health and Human Services declared a public health emergency under the Public Health Service Act to aid the health care community’s response to the spread...more
The Centers for Disease and Control and Prevention (CDC) is now recommending that the general public wear face masks to help slow the spread of COVID-19. Along with this recommendation, many businesses, individuals, and other...more
Report on Supply Chain Compliance 3, no. 9 (April 30, 2020) - Companies that are switching production lines to help produce critical medical equipment have a measure of liability immunity under the Public Readiness and...more
In response to increased concerns regarding insufficient personal protective equipment (“PPE”), the FDA recently issued an Emergency Use Authorization (“EUA”) applicable to face masks for use by both the general public and...more
As the COVID-19 pandemic continues to strain the manpower and protective tools necessary to combat the spread of infectious disease, many companies are stepping up efforts to produce, modify and/or distribute essential...more
Component part manufacturers of important lifesaving and life-protecting equipment have been essential players in the first line of defense against the COVID-19 pandemic. In the previously normal legal context, these...more
On April 14, 2020, the Department of Health and Human Services (HHS) General Counsel issued an advisory opinion (“the Opinion”) on the March 10, 2020 Public Readiness and Emergency Preparedness Act (“PREP Act”) Declaration...more
On April 14, 2020, the General Counsel for the Department of Health & Human Services (HHS) issued an Advisory Opinion (the Opinion) concerning the Public Readiness and Emergency Preparedness Act (the PREP Act) and the March...more
On March 18, 2020, the President signed into law the Families First Coronavirus Response Act, H.R. 6201, Pub. L. No. 116-127 (the “Coronavirus Response Act”). Among other measures in response to the current pandemic, this...more
On March 17, 2020, pursuant to the Public Readiness and Emergency Preparedness Act (PREP Act) and the Pandemic and All-Hazards Preparedness Reauthorization Act, HHS Secretary Alex M. Azar II issued a declaration (Declaration)...more
Earlier this week, we discussed current trends and future implications of COVID-19 on businesses operating in the products arena, noting the most direct impact so far on the pharmaceutical and medical device spaces....more