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 Your clinical decision support software may now be regulated by FDA as a medical device: 4 key takeaways from FDA’s webinar on the Final CDS Guidance 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 Advocate General against a stricter standard of proof of harm in merger cases 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 The potential for unintended consequences in the Inflation Reduction Act 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 EU Pharma & Medical Device Regulation 2023 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 The latest legislative changes in the pharmaceutical industry in Poland 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 Organoids: science fiction or the future of pre-clinical studies? 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 New IFPMA/EFPIA guidance on social media and digital channels By Marco de Morpurgo Carlotta Busani The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical...
Oct 03, 2022 Your clinical decision support software may now be regulated by FDA as a medical device By Bethany Hills Danny Tobey Dan Kagan Jianyuan Hua +1 more... Show less Clinical Decision Support (CDS) software is an area driven by innovative technologies that is often intertwined with traditional clinical...