Hospice Insights Podcast - Where’s the Line: When Does Poor Quality Create False Claims Liability
AI Today in 5: August 22, 2025, The Angst Episode
Point-of-Sale Finance Series: Understanding the Development and Regulation of Buy Now, Pay Later Products — The Consumer Finance Podcast
Daily Compliance News: August 21, 2025, The Fabricated Evidence Edition
Understanding BBB Ratings: Strategic Approaches to Consumer Complaints — Regulatory Oversight Podcast
The Road to Regulation: Vehicle Service Contracts Explained — Moving the Metal: The Auto Finance Podcast
Hospice Insights Podcast - Hospice Audit Updates: Hospices Fare Well in Federal Court
Podcast - An Overview of State Attorney General Consumer Protection Enforcement
LathamTECH in Focus: Move Fast, Stay Compliant
AI Today in 5: August 5, 2025, The AI at the SEC Episode
Episode 381 -- NAVEX's 2025 Annual Hotline Report
Podcast - Regulating AI in Healthcare: The Road Ahead
Daily Compliance News: August 1, 2025, The All AI Edition
Wild Times for the Community Reinvestment Act
Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Understanding BBB Ratings: Building Trust and Mitigating Risks — Regulatory Oversight Podcast
Daily Compliance News: July 23, 2025 the Pardon in the Wind? Edition
Top challenges with Compliance Management
Solicitors General Insights: The Tale of Two Washingtons — Regulatory Oversight Podcast
The Capital Ratio Podcast | Entering the US Banking Market
On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more
The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more
On June 17, 2025, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency is creating a new pilot program called the Commissioner’s National Priority Voucher (CNPV). The program is intended...more
The new ministerial guidance letter (‘LOM’) intended to guide the Economic Committee for Health Products (‘CEPS’) on the pricing strategy for pharmaceutical products and medical devices has been signed and published on 5 May...more
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more
On January 23, the U.S. Court of Appeals for the Second Circuit affirmed a district court ruling that Martin Shkreli, CEO of Vyera Pharmaceuticals (Vyera), violated federal and state laws by engaging in illegal and...more
On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more
On 3 March 2020, the Spanish Council of Ministers, based on Article 3(3) of the Spanish Regulation on Medicinal Products (RDL 1/2015), agreed on a new economic regime for orphan medicinal products. ...more
Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more
The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
ACI is delighted to present our inaugural Think Tank on Rx Drug Advertising and Promotion. Attend this intimate and in-depth symposium where the “who’s who” of pharmaceutical advertising and promotion will gather to discuss...more
At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more
Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more
The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more
U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more
California recently passed Assembly Bill 315 to create greater regulatory oversight of pharmacy benefit managers (“PBMs”). The bill requires PBMs to provide more transparency regarding their operations. PBMs will have to...more
On November 2, 2018, CMS issued the CY 2019 OPPS/ASC Final Rule, further cutting reimbursement for 340B Program purchased drugs. CMS finalized its proposed rule and expanded the reimbursement reductions for separately-payable...more
On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more
We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them....more
On September 11, 2018, the American Hospital Association (AHA) and other major health care industry groups sued the Department of Health and Human Services (HHS), seeking to have the U.S. District Court for the District of...more
On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor, Health and Human Services (HHS), and Education, attaching to it a large...more
The 340B Drug Pricing Program has spawned two antitrust lawsuits related to CVS’s acquisition of Wellpartner, a 340B administrator. 340B administrators contract with 340B covered entities (e.g., hospitals) to provide a...more
The leadership of the House Energy & Commerce Committee has called upon the Federal Trade Commission to undertake a retrospective review of past mergers involving pharmacy benefit managers (PBMs). ...more
Our local pharmaceutical environment is highly regulated.The most important legislative provisions are found in the Medicines Act and the Pharmacy Act....more