Regulatory Compliance

It’s been awhile since I’ve written about FDA warning letters, so I thought I would take a look at the letters issued throughout the year and see if anything egregious (or at least interesting) came up. I was surprised to learn that the FDA issued letters to six separate clinical investigators, and I thought the […]

Pharmaceutical companies selling their products in the UK need to consider the impact Brexit will have on their operations. Some changes will need to be made before the UK leaves the European Union on March 30, 2019. In a press release, the European Medicines Agency (EMA) said: “The guidance document outlines the practical and simplified […]

The European Medicines Agency (EMA) is will be moving its offices from London to Amsterdam, due to the UK’s decision to withdraw from the European Union. According to a press release issued by the EMA, the relocation effort needs to be completed by the end of March 2019. The EMA currently employs close to 900 […]

Adjusting to the new regulatory environment Recent problems with bank employees opening unauthorized accounts for consumers have focused the regulatory spotlight on sales practices in the industry. The fallout from sales practices problems has been spectacular and well-publicized: Hundreds of millions of dollars in fines and legal costs Destruction of shareholder value Brand and reputational […]

The Recordkeeping for Timely Deposit Insurance Determination rule, more commonly referred to as 12 CFR Part 370, or simply Part 370, became effective April 1, 2017. The rule details new recordkeeping and reporting requirements for the largest depository institutions that help ensure prompt payments to consumers in the event of institutional failures. Part 370 generally […]

In our guide titled “6 Ways to Mitigate Risk in Cross-Selling for Financial Services,” we briefly touched on the use of artificial intelligence and intelligent machines, along with comprehensive processes, to fight fraud. In combination with ‘know your customer’ (KYC) processes to help catch suspicious banking activity and reduce risk through the analysis of data […]

In the recent “Shaping Digital Finance” session at the 20th Milken Institute Global Conference, Corrie Elston, chief technology officer, financial services, Google Cloud Platform, said that a financial services institution may experience 80% accuracy in detecting fraud and 99.5% false positives. As mentioned earlier, only about half of money laundering or terrorist financing incidents were […]

While anti-money laundering (AML) programs may present the biggest opportunity for machine learning to thrive, there are many issues when it comes to fighting money laundering. The number and high caliber of resources required to battle fraud in today’s highly regulated environment are immense, and the cost – of both personnel and technology required to […]

According to the U.S. Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN), “Money laundering is the process of making illegally gained proceeds (i.e., ‘dirty money’) appear legal (i.e., ‘clean’). Typically, it involves three steps: placement, layering and integration. First, the illegitimate funds are furtively introduced into the legitimate financial system. Then, the money is […]

This is the final post in a brief series of posts (five in total) designed to demystify the high cost of prescription drugs in the U.S. Today’s post focuses on the fourth and final stage the of the FDA drug approval process: post-marketing. Before we dive into the final stage, here’s a quick recap of […]

Over the past several weeks, I’ve published a series of posts that talk about how to assess and mitigate risk with your regulated IT systems. The FDA recommends using a risk-based approach to accomplish this feat, and we agree, so we laid out a four-part approach for you: Assess a system for its regulated status […]

Imagine with me: In support of your required Physician Payments Sunshine Act reporting, you integrate all of your physician payment source systems to a single platform. Some of those systems are fully integrated, while other systems – mostly legacy, built on older technology – are integrated using robotic process automation (RPA). Over the course of […]