JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
We spend a lot of time with manufacturing leaders, quality teams, and in-house counsel who are all talking about the same basic issue, just from different angles: automation, AI, data, and how far to push “digital...more
On May 6, 2026, the Food and Drug Administration (“FDA” or “the Agency”) issued a press release officially announcing a pilot program for one-day inspectional assessments. According to the press release, FDA quietly started...more
Quantum computing does not just threaten passwords and virtual private networks (VPNs). It goes straight for something legal systems rely on every day: whether digital evidence can be trusted....more
Our FDA: Compliance & Enforcement Team examines a new FDA compliance program for Center for Drug Evaluation and Research (CDER)-regulated biologics, highlighting the agency’s focus on manufacturing readiness and data...more
In this episode of Regulatory Horizons, Winston Kirton breaks down the recurring issues driving FDA Form 483s and warning letters, from data integrity and quality oversight to supplier controls and documentation gaps. If...more
The past two weeks have brought an avalanche of news related to a maturing framework of prediction markets oversight from the Commodity Futures Trading Commission (CFTC), two prominent prediction markets (Kalshi and...more
At the Westminster Legal Policy Forum conference on 26 February 2026, the dominant theme was urgency. The justice system is dealing with backlogs, rising complexity and an evidential environment shaped by digital data at...more
Making and playing music have never been so popular. The modern music technology industry has made a lot of this possible but may have reached an inflection point. ...more
Entdecken Sie die wichtigsten Prognosen für das kommende Compliance-Jahr. Dieses NAVEX-Webinar beleuchtet KI-Regulierung, neue Durchsetzungsentwicklungen und globale Standards, die die nächste Ära von Ethik und...more
2026 redéfinit la conformité. Rejoignez nos experts pour décrypter l’impact de l’IA et des nouvelles réglementations (DORA) sur votre stratégie. Inscrivez-vous !...more
Explore expert predictions for the year ahead in compliance. This NAVEX webinar covers AI regulation, enforcement updates, and emerging global standards shaping the next era of ethics and risk management....more
On December 18, 2025, the Food and Drug Administration (FDA) released a final guidance entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The guidance was issued to comply with the Food and...more
The Texas attorney general (AG) announced a $41.5 million settlement with Pfizer and Tris Pharma related to allegations that the companies provided adulterated pharmaceutical products to children and manipulated testing to...more
Being a research integrity officer (RIO) is a challenging and high-stress, high-stakes job, working to prevent misconduct and investigating allegations of fabrication, falsification and plagiarism....more
In an era where social media posts can go viral in hours, investigators and consultants do not have the luxury of waiting days or weeks to respond once information (or misinformation) has leaked into the public domain. From...more
As AI adoption accelerates across legal practice, many litigators and eDiscovery professionals are eager to tap into its power but often hit a snag when security concerns arise from the top. CIOs, compliance officers, and AI...more
The advancement of artificial intelligence (AI) in healthcare information management is an unpredictable journey, both thrilling and daunting, akin to the wild west. Healthcare accounts for over 30% of the world’s data...more
As artificial intelligence (AI) becomes central to financial crime compliance -- powering fraud detection, transaction monitoring, and sanctions screening -- internal audit faces a new challenge: How do you provide assurance...more
The U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) has significantly increased its focus on sanctions compliance for “financial gatekeepers,” including financial institutions and other firms...more
Recently, China's National Medical Products Administration (“NMPA”) released a new version of the Inspection Points for Clinical Trials of Medical Devices. This new rule replaces two previous versions published in 2016 and...more
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
Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...more
Third-party delivery (3PD) companies, like Uber Eats and DoorDash, have transformed the restaurant industry by offering customers convenience and a broader range of dining options. Most restaurants rely exclusively on 3PD...more