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Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

2021 Enforcement Horizon: New administration civil and criminal enforcement efforts

With a new administration comes new policies and enforcement priorities. Today, as we kickoff our new series “2021 Enforcement Horizon,” we take notice of what has already been a very active administration, and we consider...more

World Bank Investigations Arm Sets Anti-Corruption Priorities for 2021

In October, the World Bank Group (WBG) published its third Sanctions System Annual Report for Fiscal Year 2020 (FY20), which covers the period from 1 July 2019 to 30 June 2020. The report provides a detailed look at the...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

Braving a perfect storm: Avoiding legal and reputational risk associated with CARES Act oversight and investigations

Businesses across the United States have been battered by the COVID-19 crisis and many companies have been the recipients of unprecedented levels of economic assistance and tax relief under the Coronavirus Aid, Relief, and...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

Liability immunity under the PREP Act for COVID-19 countermeasures: what manufacturers need to know

The Secretary of HHS issued a public health emergency declaration, effective February 4, 2020, regarding COVID-19. The impact of that declaration is to trigger certain targeted liability immunity provisions under the Public...more

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