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
Daily Compliance News: July 31, 2025. The Forgotten Generation 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
On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more
Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more
FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more
On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product...more
Over the past two years, at least 15 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in...more
Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more
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
Arizona AG Kris Mayes and D.C. AG Brian Schwalb submitted a letter to the FDA in support of other state AG’s 2022 petition for reconsideration of a multistate petition seeking FDA actions on toxic heavy metals in food...more
Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more
In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This program guides FDA inspectors...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
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
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. On June 9, HHS Secretary Robert F. Kennedy, Jr., announced that he is “retiring”...more
On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more
On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...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
In the first major enforcement action involving the importation of illegal tobacco products by the new administration, and on the heels of the appointment of the new acting director of the U.S. Food and Drug Administration...more
Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...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
In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more
In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...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