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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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Publications

News

FDA advises drug manufacturers on best practices for restarting operations during COVID-19 pandemic

On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public...

News

The EFPIA’s response to the EMRN’s strategy to 2025 focuses on real world evidence

On 8 September 2020, the European Federation of Pharmaceutical Industries and Associations (EFPIA) issued a statement in response to the European Medicines Regulatory Network’s (EMRN) ...

News

COVID-19 Report for Life Sciences and Health Care Companies

The COVID-19 Report is a compilation of coronavirusnews, analysis, and insightsfrom around the worldto helplife sciences and health care companies stay current in...

News

German MoH confirms admissibility of supply of kits for SARS-CoV-2 lab tests to medical laypersons

For months now there has been ongoing controversial debate about whether or not specimen-collecting kits for the detection of a SARS-CoV-2 infection or related antibodies may be furnished...

Hogan Lovells Publications

First courts consider application of PREP Act Immunity in the context of removal

Earlier this year, we published various articles breaking down the March 10, 2020 Public Readiness and Emergency Preparedness Act (PREP Act) Declaration (the Declaration) related to...

Published Works

Bad News for Device Sponsors: Panel Meetings were Already Going the Way of the Homework Assignment, and COVID Might "Put the Nail in the Coffin" Food and Drug Law Institute

Counsel Kristin Zielinski Duggan and associate Sandra Milena McCarthy co-authored an article published by the Food and Drug Law Institute titled "Bad News for Device Sponsors: Panel...

News

COVID-19 Report for Life Sciences and Health Care Companies (14 - 18 September 2020)

The COVID-19 Report is a compilation of coronavirusnews, analysis, and insightsfrom around the worldto helplife sciences and health care companies stay current in...

News

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or...

News

COVID-19 Report for Life Sciences and Health Care Companies (7 - 11 September 2020)

The COVID-19 Report is a compilation of coronavirusnews, analysis, and insightsfrom around the worldto helplife sciences and health care companies stay current in...

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