10 For 10: Top Compliance Stories For the Week Ending August 16, 2025
Moving Beyond the Usual Helpline Data
Episode 381 -- NAVEX's 2025 Annual Hotline Report
Podcast - Regulating AI in Healthcare: The Road Ahead
Great Woman in Compliance: The Power of Vulnerability with Cricket Snyder
Everything Compliance: Shout Outs and Rants: Episode 157, No To Ukraine Corruption
Avoiding a Bored Board
Podcast - Tips for Maintaining FTC Compliance When Using AI
Daily Compliance News: July 22, 2025, The I-9 Hell Edition
FCPA Compliance Report: Ethical Challenges in AI, Data Protection, and Sports with Andre Paris
Compliance into the Weeds: Boeing’s New Safety Initiatives and Compliance Reforms
Great Women in Compliance – Compliance is the Floor, Ethics is the Ceiling with Ellen Hunt
Great Women in Compliance: Creating Space to Speak Up: The Story Behind Psst.org
Regulatory Ramblings: Episode 64 – Building Inclusion Through Sustainable Leadership / The EU Omnibus Proposal with Janet Ledger and Dr. Inna Amesheva
Hidden Fees in the Live-Event Ticketing and Short-Term Lodging Industries
Digital Planning Podcast Episode: Estate Planning and the Corporate Transparency Act
Episode 330 – Halyna Senyk on Anti-Corruption Progress in Ukraine
ESG Masterclass — ESG and Impact Investing
FCPA Compliance Report – Jonathan Wilson on The NSBU Decision
Áine Bryn of Mercer UK on Demonstrating the Strategic Credibility of the Marketing Function - Passle's CMO Series Podcast
On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more
On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more
In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more
Amidst the usual suits and blazers, white dresses and tuxedos have been appearing with increasing frequency around the Georgia State Capitol this spring. Apparently word is out amongst the city’s photographers that the...more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more
HTA Methods Guide – On November 28, 2024, Canada’s Drug Agency (CDA) launched a consultation on its first-ever methods guide. The consultation seeks stakeholder input to enhance the methods guide, which describes the methods...more
On November 26, 2024, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year 2026 proposed rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more
The 2024 election results will create significant tailwinds for Republican legislative and regulatory priorities in US Congress, federal agencies, and state houses across the country. This On the Subject considers the outlook...more
New Jersey AG Matthew Platkin announced the adoption of new rules designed to promote greater transparency in prescription drug pricing. The new rules implement recently enacted legislation intended to control prescription...more
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
A group of 21 Democratic AGs filed an amicus brief with the U.S. Court of Appeals for the Ninth Circuit supporting Oregon in its defense of H.B. 4005, which requires pharmaceutical manufacturers to report certain information...more
The German federal and state data protection authorities published guidelines for the implementation and use of AI in compliance with the European Union's regulation of personal data ("Guidelines")....more
Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more
Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels. In particular, 2023 was a fertile year for PBM legislative initiatives....more
Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more
Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...more
Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and...more
On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)—ruling that the Act’s annual price increase...more