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
From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
Join us as we celebrate the 25th Anniversary of ACI’s Annual Flagship Conference on Drug & Medical Device Litigation! ACI’s Drug and Medical Device Litigation has united the greatest minds of the pharmaceutical and medical...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
The FDA announced on October 7 that it will no longer review requests for Emergency Use Authorizations (EUAs) for COVID-19 laboratory developed tests – so called “LDTs.” This is a substantial change in Agency policy. From...more
With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19...more
We're excited to bring you issue 77 of our "International products law review" with insights and updates on all aspects of products law. In this issue, provide updates on COVID-19, address promoting the circular economy...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
Our national response to the COVID-19 pandemic has been made more difficult by a shortage of personal protective equipment and lifesaving drugs and medical devices. Some evidence suggests that manufacturers’ fear of lawsuits...more
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...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
President Donald Trump signed the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) into law on March 27, 2020, to help mitigate the economic effects of the Coronavirus Disease 2019 (COVID-19) pandemic....more
Since invoking its powers under the PREP Act last month to shield certain actors aiding in the fight against COVID-19 from tort liability for their efforts, the Department of Health and Human Services (“HHS”) has been...more
Answers to frequently asked questions on who is eligible for PREP Act protections, which products are covered, and what activities will be immunized. PREP Act guarantees of immunity are available to those who manufacture,...more
As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness...more
The novel coronavirus (“COVID-19”) pandemic has given Department of Veterans Affairs (“VA”) contractors several powerful new tools in their toolbelts, and VA contractors should not leave available protections on the table. VA...more
Recently, my colleagues Colin Kelly, Caroline Gieser, Michael Polatsek, and I thought about the role that additive manufacturing (3D-printing) is playing in today’s brave new world....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
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more
COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public...more