9/6/2022 3:48:58 PM U.S. Court of Appeals rules AI cannot be named an inventor By Anette Gaertner Christine Morgan Allison Haas According to the U.S. Court of Appeals for the Federal Circuit’s August 5th ruling in Thaler v. Vidal, No. 2021-2347 (Fed. Cir. 2022),...
4/7/2022 4:04:34 PM FDA finalizes guidance on voluntary recalls, issues recommendations for industry By Kevin Madagan Matt Loughran The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products....
7/13/2021 5:35:53 PM Here we go again – Unified Patent Court back on track By Anette Gaertner The German Constitutional Court issued a landmark decision with implications for many companies doing business in Europe on July 9, 2021....
6/3/2021 12:00:38 PM A multi-agency pharmaceutical task force looks to review antitrust issues that arise during mergers and acquisitions By Lisa Baird A task force, composed of key antitrust enforcement agencies including the Federal Trade Commission (FTC), and the Canadian Competition...
10/28/2020 4:49:21 PM Join Us: Virtual Life Sciences CLE Week for In-House Counsel: November 9-13 By Lisa Baird Reed Smith is pleased to present a virtual life sciences CLE week from November 9 – 13, covering hot litigation and regulatory topics of...
4/16/2020 5:30:05 AM California Governor Relaxes Telehealth Regulations During COVID-19 Emergency By Kimberly Gold Alexis G. Cocco James Hennessy Emily Lynch +1 more... Show less California Governor Gavin Newsom’s Executive Order N-43-20 (the Order), which went into effect on April 3, 2020, relaxes various...
3/25/2020 2:39:29 AM Medical Device Manufacturers Could Be Affected by Recent CMS Guidance to Health Care Providers By Lisa Baird Medical device manufacturers, who may already be seeing the effects of lessened demand stemming from a slow-down of elective procedures...
2/10/2020 3:26:24 PM FDA announces information collection on “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion” By Cori Goldberg Sung Park On January 28, 2020, the Food and Drug Administration (FDA) announced that the Office of Prescription Drug Promotion (OPDP) will conduct...
11/26/2019 11:00:40 AM Eleventh Circuit hears oral argument in key FCA materiality case By Megan Engel On Wednesday, November 20, a three-judge panel of the U.S. Court of Appeals for the Eleventh Circuit heard oral argument in the closely...