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FDA issues new policy for evaluating impact of viral mutations on COVID-19 tests

The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The...

Hogan Lovells Publications

Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...


A step in the right direction: Encouraging diversity in clinical trial populations

On November 9, 2020, the U.S. Food and Drug Administration (FDA) released a final version of its guidance, Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria,...

Published Works

Pandemic accelerates expanding role of real-world evidence in FDA medical device submissions Med Device Online

Kelliann Payne, Blake Wilson, and Megana Sankaran authored the article titled "Pandemic Accelerates Expanding Role Of Real-World Evidence In FDA Medical Device Submissions" for Med Device...


FDA authorizes first diagnostic test for screening people without known or suspected COVID-19 infection

On July 24, 2020, the U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: (1) testing ...


FDA proposes annual summary reporting requirements for Right to Try drug sponsors, manufacturers

On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational...


COVID-19 update: Facilitating diagnostic test availability for asymptomatic testing, sample pooling

On June 16, the U.S. Food and Drug Administration (FDA) posted updates to their Molecular Diagnostic Templates for developers that intend their assay to be used for pooled patient samples...


Senate bill proposes laboratory developed tests to be regulated under CLIA process

U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the...


COVID-19’s impact on clinical trials prompts FDA to issue guidance to assist with study conduct
Registered Content

On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic." The guidance...

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