Episode 374 -- Justice Department Resumes FCPA Enforcement with New, Focused Guidance
Cruising Through Change: The Auto-Finance Industry’s New Era Under Trump Unveiled — The Consumer Finance Podcast
2023 CRA Rule Repeal: Lessons to be Learned
The Classification of Gasoline & Gasoline Fumes as a Carcinogen: Considerations for Corporate Executives & Attorneys
Hot Topics in International Trade - Let's Be Serious-Supply Chain Audits
Regulatory Rollback: Inside the CFPB’s FCRA Guidance Withdrawal — The Consumer Finance Podcast
Cruising Through Change: The Auto-Finance Industry’s New Era Under Trump Unveiled — Moving the Metal: The Auto Finance Podcast
Regulatory Rollback: Inside the CFPB's FCRA Guidance Withdrawal — FCRA Focus Podcast
Innovation in Compliance: The Critical Importance of Mobile Application Security: Insights from Subho Halder
2 Gurus Talk Compliance: Episode 53 – The AI as a Whistleblower Edition
Compliance Tip of the Day: Internal Controls for Third Parties
Healthcare Enterprise Risk Management
GILTI Conscience Podcast | Navigating Brazil's New Transfer Pricing Landscape: A Shift to OECD Standards
Importance of Compliance Management in times of transition
Great Women in Compliance: From Hotline to Headline: The DOJ’s Whistleblower Awards Reboot with Mary Inman and Liz Soltan
Compliance into the Weeds: Autonomous AI Whistleblowing Misconduct
Understanding MALPB Charters: A Collaborative Approach to Banking Innovation — Payments Pros – The Payments Law Podcast
Law Firm ERGs Under Scrutiny: Navigating Compliance, Risk, and Culture - On Record PR
Compliance Tip of the Day: Risk Assessments and Internal Controls
Abbreviated New Drug Applications and 505(b)(2) Applications - This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug...more
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
The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation involving this class of drugs. Over the past few years, litigation has focused on a wide...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 chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....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
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be no exception to this rule, and with its arrival we examine FDA’s activities...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
On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives...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