The Universal Device Identification (UDI) system was developed by the U.S, Food and Drug Administration (FDA) as global UDI compliance to protect patients and clinicians by improving traceability of medical devices through a common and shared system. It has and continues to fulfill its role in safety and traceability tenfold and medical device software has […]
“The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The final rule is a key component of the FDA’s New Era of […]
The Federal Drug Administration (FDA) provides regulation for food, drugs, medical devices, radiation-emitting products, vaccines, animal and veterinary products, cosmetics, and tobacco products. Just in the radiation-emitting products category alone, they are responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the U.S. That is a lot of oversight! The […]
“A pediatric labeling change refers to any update to a product’s labeling to add information about safety, effectiveness, or dosing for children.” As you can imagine, the number of labeling changes to pediatric medications has increased over the years due to more research, new findings, and better information. There are a number of legislative initiatives, […]
“The FDA is prioritizing its nutrition initiatives to ensure people in the United States have great access to healthier foods and nutrition information” enabling healthier food choices. One of these initiatives is front-of-package nutritional labeling. This initiative would not be in lieu of the full nutritional facts labeling typically found on the back of most […]
“Consumers are already familiar with blue thermal paper from retailers. In many supermarkets, the new eco-receipts are increasingly replacing the previous white versions to use sustainable paper.” There is a new material that a German company, VPF, has developed and it is free of chemical developers so it is approved to be put directly on […]
For consumers, reviewing nutritional labels is commonplace though what to pay attention to has changed over the decades. We often think of these labels as a convenience but in reality, they are a requirement. The FDA reviews and makes changes to the nutrition facts label when needed. The latest updates came in 2016 “to […]
In the food and beverage industry, the packaging is everything. It is the first thing customers see and maybe the initial reason a consumer considers your product. Lakeview Farms, a manufacturer of dips, desserts, and specialty products, found that their manual artwork management process was both time-consuming and lacked stakeholder visibility, which reduced […]
A statistic in November 2021, noted the pharmaceutical industry in the United States was worth around 2.8 trillion dollars. This is a significant increase from just a year prior when it was valued at 1.27 trillion. While there are many factors that play into the massive increase, one of them is what people pay for […]