Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more
On June 12, 2025, Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduced the End Prescription Drug Ads Now Act (the Act) that would prohibit pharmaceutical companies and arguably any other entity engaged in...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
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
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
State attorneys general (AGs) continue to play a pivotal role as innovators, shaping the regulatory environment by leveraging their expertise and resources to influence policy and practice. The public-facing nature of AG...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
Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more
Peter Murphy’s 1989 single, “Cuts You Up,” came to mind when we read FDA’s Office of Prescription Drug Promotion’s (“OPDP”) latest Notice of Violation....more
In 1984, the international rock band, The Scorpions, released the song, “Rock You Like a Hurricane.” Forty years later, the Food and Drug Administration’s Office of Prescription Drug Promotion rocked a pharmaceutical company...more
Much like how Ray Charles lamented in 1967, the pharmaceutical industry is saying, “Here we go again, she’s back in town again,” as the Food and Drug Administration issued its second Notice of Violation in a month. Last week,...more
In 1987, the influential garage rock band, The Replacements, led by Paul Westerberg, sang, “I can’t hardly wait.” Years later, the Food and Drug Administration issued a Notice of Violation — the second this year — to a...more
In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more
Welcome to the Class Action & MDL Roundup, our quarterly review of decisions and settlements in the class action arena. In this edition, student-athletes win an NIL round, Canadians in California isn’t personal...more
What You Need To Know In A Minute Or Less - The current industry trend “beauty from within” refers to a focus on wellness—namely physical, mental, and lifestyle—and its impact on beauty. Oral supplements that consumers can...more
Better Than Ezra’s early 1990s single, “This Time of Year,” came to mind when we saw the Food and Drug Administration’s Office of Prescription Drug Promotion issue its first Untitled Letter (also known as a Notice of...more
In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and...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
On December 26, 2023, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a Questions and Answers Guidance for industry titled “Direct-to-Consumer Prescription Drug Advertisements:...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more
In 1972, Johnny Nash sang the catchy song, “I Can See Clearly Now.” A little more than 50 years later, the Food and Drug Administration’s Office of Prescription Drug Promotion issued a Final Rule relating to...more
On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers. The FDA first issued its proposed rule in 2010, which subsequently went through three public comment...more
In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription...more