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 […]
“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 […]
We have heard a lot through the news lately of drug shortages, mostly over-the-counter cold and flu medications, but what is the process when prescription drugs are in short supply? The FDA works closely with the pharmaceutical industry and stakeholders to “prevent drug shortages and lessen the impact on patients anytime there is a […]
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 […]