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
The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...more
Bass, Berry & Sims is pleased to announce the release of the 13th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2024. Compiled by the firm's Healthcare Fraud & Abuse Task Force,...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As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations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
1. CONTENTIEUX - NOUVEAU RISQUE DE REMISE EN CAUSE À POSTERIORI D’OPÉRATIONS NON NOTIFIABLES - Par une décision du 2 mai 2024, l’Autorité de la concurrence (ci-après l’ « Autorité ») a fait pour la première fois...more
On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
Summary - On June 10, 2024, the District Court for the District of New Jersey ordered Teva to delist five patents from the Orange Book for ProAir® HFA (albuterol sulfate) Inhalation Aerosol. The patents were directed to...more
The European Commission has launched its first investigation into a non-EU country's procurement practices leveraging its new tool, the International Procurement Instrument. This investigation looks at the public procurement...more
The “safe harbor” of 35 USC § 271(e)(1) shields certain acts from liability for patent infringement if they are conducted “solely for uses reasonably related” to obtaining U.S. Food and Drug Administration (FDA) approval to...more
Drug and device manufacturers doing business in Nevada have upcoming filing deadlines in March, April, and June. By June 1, 2024, compliance officers must sign and submit a certification to the Nevada Board of Pharmacy to...more
Whether you manufacture a Class I elastic bandage or a Class III deep-brain stimulation device, understanding when to report a medical device complaint is critical and is also required for all FDA regulated medical devices....more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more
n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more
For diabetic patients and the doctors who treat them, blood sugar levels are crucially important. However, the traditional method of testing one’s blood sugar with a pin-prick is undesirable for many patients, which leads to...more
It was another busy month at the ITC. A Final Determination was issued by the Commission in three Section 337 Investigations: Certain Laparoscopic Surgical Staplers, Reload Cartridges, and Components Thereof, Inv. No....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
The SEC recently settled an enforcement action against Mylan N.V., claiming Mylan failed to timely disclose to investors a possible loss relating to a nearly two-year Department of Justice probe into whether Mylan...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
The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days. The guidance is intended to assist all...more
On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015. The Work Plan is a compilation of the OIG’s plans for...more
In the wake of a recent U.S. Department of Health and Human Services Office of Inspector General ("OIG") investigation, physicians with ownership interests in medical device distributorships and hospitals should prepare for...more
A recent article in the Antitrust Law Journal titled “A Survey of Evidence Leading to Second Requests at the FTC,” by Darren S. Tucker, an attorney advisor to a FTC Commissioner who reviewed non-public information on the...more
"I've long maintained that there are three possible routes to repeal of ObamaCare: the courts, the presidential election, and our constitutional responsibility for oversight. With two of them having come up short, the third...more