“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 […]
The establishment of Global Standards, a nonprofit organization that standardizes business information globally, leverages GS1 standards and services in the marketplace providing a faster listing process, improved counterfeit detection, and simplified regulatory compliance. GS1 is a common language to identify, capture, and share information globally. GS1 Standards provide unique identification of items and products that […]
When we look at the labeling regulatory environment, we often focus on critical data like expiry date, product identification information, and manufacturing date that must be present on a label. What is not realized, is the time and effort that goes into label artwork management, including design and automation. “As packaging artwork becomes more important […]
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 […]
We’ve talked a lot about moving labeling operations moving to the Cloud to gain efficiency and accuracy, but also increased security. This same security is becoming less reliable due to a lack of digital security expertise. “According to a recent survey performed by Rackspace- a provider of multi-cloud services and security, two of the top […]
The U.S. Food and Drug Administration has distributed a draft of updated recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or quality systems. Product quality and patient safety are central to identifying and promoting successful manufacturing practices. While these recommendations are simply that, recommendations, […]
“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 […]