Knowledge

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.

Follow us:

Publications

News

FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when...

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 (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...

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

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...

News

COVID-19 Report for Life Sciences and Health Care Companies (1 - 4 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

COVID-19 Report for Life Sciences and Health Care Companies (24 - 28 August)

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

New French anti-benefits regulations - the thresholds finally published

The ministerial orders setting the thresholds for the determination of the notion of negligible value of benefits provided in kind or in cash, as well as the thresholds for the agreements...

Loading data