Episode 369 -- Stepping Into the Enforcement Spotlight -- Customs and Border Patrol and Import Enforcement
Tariffs and Trade Series: What Investors Need to Know
Compliance Tip of the Day: Using Supply Chain to Innovate in Compliance
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — The Consumer Finance Podcast
Early Returns Podcast - Oliver Roberts: AI and the Law, and an Education
Compliance into the Weeds: Leaving on a (Qatari) Jet Plane
(Podcast) California Employment News: Back to the Basics of Employee Pay Days
Compliance Tip of the Day: Multiplying the Influence of Compliance
Innovation in Compliance: Navigating Regulatory Changes and Compliance in Trade and Data Privacy with Stephanie Font
Compliance tip of the Day: Communication Through Persuasion
All Things Investigations: Task Force Strategies - Addressing New Government Priorities
10 For 10: Top Compliance Stories For the Week Ending May 10, 2025
Compliance Tip of the Day: Middle Managers as the Eyes and Ears of Compliance
Everything Compliance: Episode 153, The CW 25 Edition
ADA Compliance for Medical and Dental Practices: Responding to Inquiries and Investigations
Innovation in Compliance: Exploring the Intersection of Compliance, Technology, and AI with Ben Sperry
Compliance Tip of the Day: Elevating Compliance Through Connected Middle Managers
Understanding Human Trafficking and Modern Slavery: A Business Imperative with Clint Palermo
Shout Outs and Rants: Episode 153, The CW 25 Edition
Daily Compliance News: May 6, 2025 the Made in China Edition
Hetlioz® (tasimelteon) - Case Name: Vanda Pharms., Inc. v. FDA, Civ. No. 23-280 (TSC), 2025 WL 485401 (D.D.C. Feb. 13, 2025) (Chutkan, J.) Drug Product and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patent No. , a...more
The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more
Tax developments - Actavis and deductible expenses - On March 21, 2025, the Court of Appeals for the Federal Circuit released a decision in Actavis Laboratories FL, Inc. v. United States, holding that taxpayers could...more
This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more
The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s delisting of patents from the Orange Book because the patent claims did not “claim the drug that was approved” or the active ingredient of the drug...more
In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more