False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
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
The U.S. Department of Justice announced on July 24 that Admera Health LLC, a New Jersey-based biopharmaceutical research and clinical laboratory testing company, agreed to pay $5,389,648 to resolve kickback allegations...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
The American reverence for entrepreneurial spirit and free enterprise is reflected in the profound influence of capitalism on our healthcare system. In contrast to many other advanced industrialized countries with state-run...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
In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA)...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
Under Section 3213 of Food and Drug Omnibus Reform Act, the U.S. Food & Drug Administration (“FDA” or the “Agency”) is required to establish the Advanced Manufacturing Technologies Designation Program, an initiative intended...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
U.S. health care attorneys, investors, and industry stakeholders are very familiar with the well-worn mantra that prescription drug and medical device companies are not allowed to “market” or “promote” their...more
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new...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
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
On June 27, 2023, the Food and Drug Administration (FDA) issued its final guidance for the presentation of “Quantitative Efficacy and Risk Information” in direct-to-consumer (DTC) promotional labeling and advertisements for...more
On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in...more