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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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UK regulation of medical devices from 1 January 2021
Registered Content

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ...

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

China’s NMPA releases proposal for modified “Hatch Waxman” following patent law reform

On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed regulation on patent...

News

COVID-19 Report for Life Sciences and Health Care Companies (21 - 24 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 Pre-Cert update: “more work needed” to refine Streamlined Review Framework

On September 14, the U.S. Food and Drug Administration (FDA) announced that it released an eight-page update on the status of the Digital Health Software Precertification (Pre-Cert) Pilot...

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...

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...

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