10 For 10: Top Compliance Stories For the Week Ending August 23, 2025
Daily Compliance News: August 22, 2025, The WADA Returns Edition
Operationalizing Trust at Scale: Evolving Compliance: Neta Meidav on the Diligent Acquisition and AI Integration
Daily Compliance News: August 18, 2025, The All Corruption Edition
Herb Stapleton's FBI Experience Proves to be Asset to Dinsmore's Corporate Team
False Claims Act Insights - Beyond Adversarialism: How to Steer FCA Investigations
Episode 381 -- Cadence Design Pays $140 Million to Settle Trade Violations
Adventures in Compliance: The Novels - The Valley of Fear, Sherlock Holmes’ Investigative Techniques for Today’s Challenges
LathamTECH in Focus: Move Fast, Stay Compliant
Adventures in Compliance: The Novels - The Valley of Fear, Introduction and Compliance Lessons Learned
10 For 10: Top Compliance Stories For the Week Ending, August 2, 2025
Daily Compliance News: July 30, 2025, The Corruption Kill Business Edition
Suluki Secrets: Behind the Scenes of Reasonable Investigations — FCRA Focus Podcast
Just Press "Play"
Episode 379 -- Update on False Claims Act and Customs Evasion Liability
Daily Compliance News: July 28, 2025, The Where is Grasshopper when you need him Edition
Daily Compliance News: July 25, 2025, The New Sheriff in Town Edition
Avoiding a Bored Board
Podcast - “I Lied Like a Dog!”
Daily Compliance News: July 21, 2025, The More Reasons Not to Go to China Edition
As we reported in our recent client alert, the Trump administration has made clear that it is committed to using the False Claims Act (FCA) to prosecute healthcare fraud. Two recent Trump administration moves give important...more
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation...more
McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most. Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more
Industry is revising its models in clinical development: new collaborative research between the industry and investigators is becoming more important, resulting in an in-between approach between industry sponsored studies and...more
Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators (“Investigators”) play an important role in supporting drug...more
Circuits Split Over Whether Targeting Is Necessary for Seller Liability - Key Points - - While courts have long held that solicitations must be tailored to a particular audience to precipitate statutory seller liability,...more
On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...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
On February 11, 2020, AGG’s Government Investigations practice chairs, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021...more
With the new administration poised to take office, public and private companies will need to consider how President Biden’s regulatory, enforcement, and legislative priorities will affect their businesses. During this...more
As discussed in Part I, a company’s technology must have strong intellectual property to establish a significant technology transfer program or prepare for an eventual acquisition. Establishing an intelligent IP strategy can...more
On February 21, 2018, the Food and Drug Administration (FDA) issued a final rule amending the Agency’s regulations on acceptance of data from clinical investigations form medical devices. The final rule amends requirements...more