Bethany Hills

4/10/2024 1:51:43 PM

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...

2/19/2024 3:04:14 PM

By Bethany Hills Christopher Mikson Perham Gorji +4 more...

On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses...

7/27/2023 8:26:54 AM

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The Food and Drug Administration (FDA) has released a draft guidance titled, “Good Clinical Practice (GCP) E6(R3),” explaining how the...

3/17/2023 2:01:15 PM

By Keo Shaw Bethany Hills Daniel Tobey +1 more...

On March 1, 2023, FDA’s Center for Drug Evaluation and Research (CDER) published a discussion paper on artificial intelligence (AI) in...

11/8/2022 9:52:38 AM

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....

10/25/2022 12:14:45 PM

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...

10/3/2022 2:20:32 PM

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...

9/27/2022 2:50:33 PM

By Jamie Gregorian Bethany Hills Alex Pinson +1 more...

President Joe Biden has issued an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and...