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U.S. courts continue to apply narrower view of PREP Act immunity

During the past 12 months, we’ve published several articles on the 10 March 2020, Public Readiness and Emergency Preparedness Act (PREP Act) Declaration related to COVID-19 as well as covering the five amendments to the PREP...more

Fifth Amendment to PREP Act Declaration expands "covered persons" to increase workforce authorized to administer COVID-19 vaccines

On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued its fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) related to COVID-19...more

PREP Act declaration amended to clarify coverage of certain products not directly used for COVID-19

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

International products law review 2020: Issue 77

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

HHS Issues Advisory Opinion Encouraging a Broad Reading of its PREP Act Declaration

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

HHS guidance confers PREP Act immunity to pharmacists for certain COVID-19 tests

On April 8, 2020, the Office of Assistant Secretary for Health (OASH), in the U.S. Department of Health and Human Services (HHS) issued Guidance for Licensed Pharmacists, COVID-19 Test, and Immunity Under the PREP...more

Navigating Limits on Product Liability under the PREP Act for COVID-19 Clinical Trial Activities

While numerous entities are responding with impressive speed and diligence in working to develop and deploy various COVID-19 countermeasures, some from the Plaintiffs bar are already putting up online advertisements offering...more

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