Apr 10, 2024 Inspirational Women In Life Sciences: Lisa LeCointe-Cephas, purpose and passion By Bethany Hills Hannah Gardiner This week’s featured Inspirational Women in Life Sciences is DLA Piper’s own Lisa LeCointe-Cephas, Co-Chair of the DLA Piper Life...
Feb 19, 2024 FDA’s new Quality Management System Regulation is here: Key takeaways for device companies in US, EU, and China By Bethany Hills Christopher Mikson Perham Gorji Jae Kim Adam Donat Marco de Morpurgo Ting Xiao +4 more... Show less On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses...
Jul 27, 2023 FDA aims for international harmonization and modernized clinical trials By Bethany Hills Adam Donat The Food and Drug Administration (FDA) has released a draft guidance titled, “Good Clinical Practice (GCP) E6(R3),” explaining how the...
Mar 17, 2023 FDA calls for comments on artificial intelligence in drug manufacturing By Keo Shaw Bethany Hills Daniel Tobey Geoffrey Levitt +1 more... Show less On March 1, 2023, FDA’s Center for Drug Evaluation and Research (CDER) published a discussion paper on artificial intelligence (AI) in...
Nov 08, 2022 California strengthens protections for mental health information exchanged through digital health applications By Andrew Serwin Kristi Kung Bethany Hills With the mounting mental health crisis intensified by the COVID-19 pandemic, the telemental health industry has exploded in recent years....
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 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...
Sep 27, 2022 Bioeconomy Executive Order: A whole-of-government approach to advancing biotechnology and biomanufacturing By Jamie Gregorian Bethany Hills Alex Pinson Matthew Larson +1 more... Show less President Joe Biden has issued an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and...