Episode 381 -- Cadence Design Pays $140 Million to Settle Trade Violations
On Demand, On Purpose: Fashion Manufacturing That Doesn’t Cost the Earth
Compliance Tip of the Day: AI and 3rd Party Risk Management
All Things Investigations – Navigating Secondary Tariffs with Mike Huneke and Brent Carlson
FCPA Compliance Report: The Impact of Secondary Tariffs on Global Trade with Mike Huneke and Brent Carlson
Episode 377 -- Refocusing Due Diligence on Cartels and TCOs
GILTI Conscience Podcast | Beyond the Runway: Navigating Tax, Tariffs and Transfer Pricing in Luxury Fashion
How International Companies Can Prepare for July 9 Tariffs
Hot Topics in International Trade - Let's Be Serious-Supply Chain Audits
The Future of Supply Chains: Chris Andrassy on Using AI to Predict & Prevent Disruptions
Hot Topics in International Trade - Tariff Mitigation Strategies
A Voltage Voyage With Danielle Spalding, Cirba Solutions — Battery + Storage Podcast
Compliance in the Former Soviet Central Asian Republics
Tariffs and Trade Series: What Boards of Directors Need to Know
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
Tariffs and Trade Series: What Senior Management Teams Need to Know
Wiley's 2025 Key Trade Developments Series: Trade Remedies
Understanding Human Trafficking and Modern Slavery: A Business Imperative with Clint Palermo
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
As we stride further into 2025, the pharmacy industry faces a landscape teeming with challenges and opportunities. From tackling drug price transparency to juggling implementation of artificial intelligence, the industry is...more
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the...more
The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of history, on October 2, 2024...more
On July 12, 2024, the FDA provided small dispensers—those employing 25 or fewer full-time pharmacists or pharmacy technicians—with an exemption from the Drug Supply Chain Security Act’s (“DSCSA”) enhanced drug distribution...more
On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
Earlier this month, the American Society of Pharmacy Law hosted its annual conference in San Antonio, TX. This gathering of industry leaders provided a unique opportunity to delve into the ever-evolving landscape of pharmacy...more
Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...more
The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government. Pharmacy benefit...more
On Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more
In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more
On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more
Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more
The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets...more
On February 4, 2022—more than six years after the deadline imposed by statute—the U.S. Food and Drug Administration (“FDA”) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors...more
New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug...more
340B PROGRAM - Further State Legislation Seeks to Regulate PBMs in Relation to 340B: Florida, Kentucky, Missouri, Nebraska, and New Hampshire recently introduced legislation aiming to regulate pharmacy benefit managers...more
Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more
Food - FDA Released Retail Food Employee Health Handbook – The FDA published the Employee Health and Personal Hygiene Handbook to help food employees avoid spreading viruses and bacteria to food....more
On June 8, 2020, the Food and Drug Administration (FDA or Agency) issued temporary guidance to address concerns related to distribution of drug samples during the COVID-19 public health emergency....more
WHAT ARE THEY? Sometimes the needs of a patient are so unique that prescription medications readily available at retail drug stores are not sufficient to combat the illness or treat the condition. An example of such a...more
With COVID-19 cases on the rise in the United States, some hospitals have faced shortages of FDA-approved drug products used to treat the disease. ...more