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
Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more
When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more
Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more
On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...more
Recently, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued separate communications that aim to bolster domestic drug manufacturing while tightening oversight of...more
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more
I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more
Following a hotly contested election, Donald Trump is once again the president-elect and will return to the White House on January 20, 2025. He will do so with a dominant electoral college win, potentially a win of the...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval. Generally, there are three pathways to importing a prescription drug into the United...more
Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing its policy regarding requests for the importation of unapproved finished...more
Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more
Recently, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced policies intended to permit the importation of, and Medicaid reimbursement for, certain foreign prescription...more
FDA Released Food Traceability Proposed Rule – The United States Food and Drug Administration (FDA) is proposing to establish additional traceability recordkeeping requirements for manufacturers, processors, packers or...more
As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more
On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more
The current outbreak of COVID-19 (the coronoavirus) will be a test of the global supply chain’s strength in the face of unintended interruptions, and can be a lesson on building-in supply-chain contingency plans. As a result...more
...The coronavirus (provisionally named SARS-CoV-2, with its disease being named COVID-19) has been documented in six of the world’s seven continents (sparing only Antarctica), in more than 70 countries and territories. More...more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more