False Claims Act Insights - Beyond Adversarialism: How to Steer FCA Investigations
Episode 381 -- Cadence Design Pays $140 Million to Settle Trade Violations
Fierce Competition Podcast | Antitrust Collusion in Labor Markets: Enforcement Trends on Both Sides of the Atlantic
Podcast - An Overview of State Attorney General Consumer Protection Enforcement
LathamTECH in Focus: Move Fast, Stay Compliant
Compliance Tip of the Day: Key M&A Enforcement Actions
Compliance into the Weeds: A Deep Dive into Cadence Design Systems’ Export Control Violations
Daily Compliance News: August 1, 2025, The All AI Edition
From the Editor’s Desk: Compliance Week’s Insights and Reflections from July to August 2025
Everything Compliance: Episode 158, The No to Corruption in Ukraine Edition
Mid-Year Labor & Employment Law Update: Key Developments and Compliance Strategies
Disparate Impact & Enforcement Rollbacks: What’s the Tea in L&E?
CSC Guidance Unveiled: NIL Enforcement and Implications for Collectives — Highway to NIL Podcast
Episode 379 -- Update on False Claims Act and Customs Evasion Liability
PODCAST: Williams Mullen's Trending Now: An IP Podcast - Cease and Desist Letters: Protecting Your Intellectual Property the Right Way
PODCAST: PODCAST: Williams Mullen's Trending Now: An IP Podcast - Cease and Desist Letters: Protecting Your Intellectual Property the Right Way
Data Driven Compliance: Understanding the UK’s New Failure to Prevent Fraud Offense with Sam Tate
Daily Compliance News: July 25, 2025, The New Sheriff in Town Edition
Quick Guide to Administrative Hearings
Compliance into the Weeds: Sanctions Compliance Failures: Lessons from Harman International and Interactive Brokers
The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more
Connecticut Attorney General (AG) William Tong has taken legal action against two online distributors, Triggered Brand and Made In China, for allegedly selling research-grade GLP-1 weight loss drugs directly to Connecticut...more
Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more
Connecticut AG William Tong announced enforcement actions against companies that allegedly advertised, distributed, or sold so-called “research grade” versions of GLP-1 weight loss drugs in violation of state consumer...more
FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more
When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more
Reckitt Benckiser Tastes Sweet Success as Mucinex Honey False Ad Dismissed - Plaintiffs alleging that Reckitt Benckiser falsely advertised certain Mucinex products as containing honey failed to sufficiently allege that the...more
When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
The wait is finally over. On June 7, 2023, after remaining silent for over an entire year, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first untitled letter of 2023 to...more
Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more
After two years of decreased enforcement activity (with an out-sized portion of activity being COVID-19-related), the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued several Untitled...more
“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more
Who doesn’t remember Hall and Oates’ 1984 hit, “Out of Touch?” Perhaps, reviewers in the Food and Drug Administration’s Office of Prescription Drug Promotion were humming this song when it recently issued an Untitled Letter...more
In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more
Does anyone remember the 1980’s song, “Freeze-Frame” by The J. Geils Band? A new year, a new Untitled Letter issued by the Food and Drug Administration’s Office of Prescription Drug Promotion to a prescription drug company....more
Late last year, the Food and Drug Administration’s Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful promotion of its biologic product....more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Good riddance to 2020 for so many reasons. But, as the AGG Year in Review of the Food and Drug Administration’s enforcement of prescription drug advertising and promotion has become an annual ritual, let’s take a quick peek...more
The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more
On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more
On June 5, 2019, the Department of Justice (DOJ) announced a global settlement with Insys Therapeutics (Insys) that preliminarily resolves criminal and civil cases against the opioid manufacturer in a number of jurisdictions....more