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HHS Broadens Scope of PREP Act Immunity for Individuals and Entities Fighting COVID-19

On December 3, 2020, the Secretary of the Department of Health and Human Services issued a fourth amended PREP Act declaration expanding the scope of immunity for covered entities engaged in the provision of goods and...more

FDA Releases COVID-19 Vaccine Guidance for Industry

On June 30, 2020 the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research released its first “Guidance for Industry” document for the development and licensure of COVID-19 vaccines. While the...more

HHS Amends Tort Immunity Declaration Under the PREP Act to Clarify that Immunity Extents to Products that “Limit the Harm”...

As we previously reported, on March 10, 2020, the Secretary of Health and Human Services, acting under the authority provided by the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act), issued a Declaration...more

HHS Issues Advisory Opinion Further Clarifying Scope of PREP Act Immunity

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

HHS Provides Limited Tort Immunity to Companies Providing Pandemic Response Countermeasures under the PREP Act

“This is a rapidly evolving situation and CDC will provide updated information and guidance as it becomes available.” This statement is the headline to the CDC’s Situation Summary for COVID-19. ...more

FDA Withdraws Proposed Rule Abolishing Generic Preemption; Recognizes “Downsides” Of Expanded Tort Liability

On December 13, 2018, the FDA withdrew a proposed rule that would have authorized manufacturers of generic drugs to use the Changes Being Effected (CBE) procedure to add new safety information to their labeling—something that...more

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