Kelliann Payne

Hogan Lovells

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Latest Posts › Coronavirus/COVID-19

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COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

In Tuesday's Report: the expanding role of real-world evidence in FDA medical device submissions; President-elect Joe Biden lays out COVID-19 plan; Pfizer announces vaccine efficacy; and an analysis of material adverse change...more

11/11/2020 / Biden Administration , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Infectious Diseases , Japan , Life Sciences , Material Adverse Change Clauses (MACs) , Pfizer , Real World Evidence , Vaccinations

Helping companies navigate the COVID-19 pandemic

Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on nearly 200 matters, ranging from...more

7/15/2020 / Business Disruption , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Supply Chain , Telehealth

In midst of COVID-19, FDA reminds industry that it plays both good and bad cop

U.S. authorities are actively policing entities making illegal promotional claims that products mitigate, prevent, treat, cure, or diagnose COVID-19....more

3/30/2020 / Advertising , Coronavirus/COVID-19 , Diagnostic Tests , Emergency Use Authorization (EUA) , FDA Warning Letters , Food and Drug Administration (FDA) , Fraudulent Marketing , Regulatory Standards , Regulatory Violations

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