We have shared many articles about the highly regulated pharmaceutical industry. Still, we don’t often think about all the other products the FDA may periodically come across through inspections that we don’t categorize as pharmaceuticals. A well-known natural ingredient toothpaste brand needed to make swift changes when the FDA accused the toothpaste maker of bacteria-tainted […]
When we think of counterfeit, we often think of money or high-end products. Rarely do we consider food an item of concern for counterfeiting, yet “the FDA estimates that food fraud, which commonly includes incorrect expiration dates or the incorrect listing of ingredients, is costing the industry as much as $40 billion a year.” Loftware […]
We have shared how cloud-based labeling solutions can benefit so many industries and the food and beverage business is no different. Artificial Intelligence combined with the Cloud is revolutionizing food and beverage supply chains. “Leveraging AI alongside cloud technology has emerged as a powerful enabler for automating complex tasks and ensuring food and beverage product […]
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, […]
We recently wrote about the Hatch-Waxman Act and the negotiation that occurred to allow for longer patents for new drugs on the market. Now we dive into skinny labels, what they are, and how they may prevent brand-name drug manufacturers from delaying the competition. In this blog, we will share the skinny, on skinny labels. […]
How is it that we have a “prescription drug price crisis when 90% of prescriptions are filled with generic drugs that cost, on average, $1 a day? The answer: The remaining 10% of prescriptions have an average cost of $20 a day and account for 80% of all prescription drug spending.” The intent of the […]