Corrected or not corrected? The IA will know the answer. On November 12, 2015 the Centers for Medicare and Medicaid Services (CMS) released the HPMS memo entitled, Independent Auditor (IA) Validation Process for Medicare Advantage and Prescription Drug Plan Program Audits. Beginning with the 2015 program audit results and going forward, CMS will require a [...]
For over 30 years, with over 500 sites and over a billion people, India was a key destination for clinical trials with its vast treatment naïve clinical population. However, the environment has fluctuated throughout recent years, as The Central Drugs Standard Control Organization (CDSCO), India’s regulatory agency for clinical research, introduced regulations that have shifted [...]
An “Ecosystem” can be defined as a complex system or network which is interconnected around a specific subject or area. This means that many nodes or elements support the various aspects of the ecosystem and they are all interdependent. Learning within an organization is similar. Organizations are complex networks and when you want to make [...]
Posted on 13. Apr, 2016 by Jefferson Barr.
In the 1980s, milk did a “body good.” In the 2010s, moving beyond basic compliance training does an “organization good.” A disciplined compliance training process serves as the foundation for measurable “business outcome” programs that can improve employee performance and drive higher business performance. UL EduNeering was recently featured in CIO Review Magazine as one [...]
Many people don’t realize that the FDA has offices around the world. According to the FDA website, “The Office of Global Regulatory Operations and Policy (also known as GO) comprises the Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP). The Deputy Commissioner for GO provides executive oversight, strategic leadership, and policy [...]
Recently, the White House budget request was released and in that release for fiscal 2017 was an “ask” for $1.1 billion to combat opioid abuse. Most of the requested money would go to fund state programs to make treatment more available and easier to afford. States with higher rates of opioid abuse and strong plans [...]
14 years after Jurassic Park, sci-fi fans got Jurassic World. Now, 14 years later cancer patients are getting their generic! As of February 1, 2016, a generic version of Imatinib Mesylate 100mg and 400mg (Gleevec®), the first targeted cancer drug, is available to cancer patients as an option to the brand drug. Approved by the [...]
Posted on 28. Mar, 2016 by Karl Kapp.
With all the commotion and recent Congressional hearing appearance by the infamous Martin Shkreli, the CEO of a drug company that hiked a drug price from $13.50 to $750, the industry is taking a lot of heat and the commotion is providing opportunities for disruptive services. A few entrepreneurial companies are attempting to change the [...]
In healthcare, the term “interoperability” means the ability of different information technology systems and software applications to communicate, exchange data, and use the information that has been exchanged. In fact, some have called it a “plug and play” solution. The FDA has recently indicated a focus in this area as related to medical devices, stating [...]