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
Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...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As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations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
Even the best company is not perfect. Mix ups, mathematical errors, transposing numbers, forgetting to sign a batch production, a supplier mix-up, or any one of an almost infinite potential glitches in the very complex...more
On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...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
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
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
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more
In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...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
The U.S. Environmental Protection Agency (EPA) is not the only federal agency that regulates per- and polyfluoroalkyl substances (PFAS). And states aren't the only ones scrutinizing PFAS in food packaging products. PFAS,...more
The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August...more
In the second edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administrations’ (FDA) expectations of investigators articulated in the recently released draft guidance....more
FDA and FTC Issue Cease and Desist Letters to Companies Selling Delta-8 Edibles - On July 5, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly sent cease and desist letters to six companies...more
The Food and Drug Administration (FDA) recently issued first-of-its kind draft guidance for investigational new drug (IND) applications involving psychedelic drugs. Citing the rise in interest in exploring the potential...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more
Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more
IV hydration clinics engage in sterile compounding activities (combining or mixing ingredients to create a custom drug/medicine for an individual patient), such as creating IV vitamin therapies, etc. This act of drug...more
The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...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