Cortex – Life Sciences Insights

Oct 28, 2022

Considering Modifications to Existing FDA Regulatory Incentives to Achieve Greater Racial and Ethnic Diversity in Clinical Trials for Drug Approvals

By Kirsten Axelsen

When clinical trials for new drug approvals fail to adequately represent racial and ethnic groups, there is a lost opportunity to collect...

Oct 25, 2022

By Keo Shaw Bethany Hills Danny Tobey

In the wake of FDA’s long-awaited final guidance for the regulation of Clinical Decision Support Software, many software developers and...

Oct 21, 2022

By Joost Haans

Yesterday (20 October 2022), Advocate General (AG) Kokott of the European Court of Justice issued her Opinion in relation to the appeal...

Oct 20, 2022

By Jim Greenwood Alex Pinson Jamie Gregorian

The Inflation Reduction Act (IRA) significantly impacts the US economic model for prescription drug innovation through the imposition of...

Oct 19, 2022

By Marco de Morpurgo Nicola Landolfi

Our EU Life Sciences Regulatory team led by Marco de Morpurgo and Nicola Landolfi have produced a guide on EU Pharma & Medical Device...

Oct 12, 2022

By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Urszula Grębowska

In our latest report, we provide an update on the key legislative changes proposed and introduced in the pharmaceutical sector in Poland.

Oct 10, 2022

By Marion Abecassis Ruth Faragher

New technologies based on human cells are increasingly seen as key to reducing the time and cost in bringing drugs to market. This is an...

Oct 06, 2022

By Marco de Morpurgo Carlotta Busani

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical...

Oct 03, 2022

By Bethany Hills Danny Tobey Dan Kagan +1 more...

Clinical Decision Support (CDS) software is an area driven by innovative technologies that is often intertwined with traditional clinical...