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The intricacies of FDA regulations

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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 […]

5 Ways Inefficient Labeling can Impact ROI

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Whenever organizations consider a new investment in the business, the return on investment is a vital component of the decision-making process. Maximizing the ROI is critical when looking to make capital investments. Companies must also consider that not making the investment or working within inefficient processes could have even more impact on their ROI. BarTender […]

EU Food Allergen Labeling

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In the United States, we are quite familiar with the Food and Drug Administration (FDA) and its involvement in food and drug production. FDA is responsible for “protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that […]

The A-Z glossary of medical labeling

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In the medical field, names and terms can be a bit overwhelming, from elaborate pharmaceutical names to medical diagnoses.  Medical labeling is almost as complicated, so Loftware has put together an A-to-Z glossary for medical labeling. “The world of regulated label management has its share of highly specialized and technical language.” This article provides links […]

Pediatric Labeling Changes

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“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, […]

NFC tag provides solution for medical supplier

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When working within a medical laboratory or pharmaceutical arena, extra care must be taken to ensure safety, clarity, and accuracy. This doesn’t change when it comes to the labeling process.  Our partners at BarTender were able to find a solution for a medical supplier using NFC tags to uniquely identify containers “while maintaining information clarity […]

What’s the skinny, on skinny labels?

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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. […]

The Hatch-Waxman Act and pharmaceutical costs

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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 […]

Supplier labeling and the Cloud

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Many organizations require third-party vendors like suppliers, contract manufacturers, and third-party logistics providers to deliver their product labeling. Compliance labeling requires clear and consistent processes and organizations spend time and money to ensure their labels are accurate.  Many organizations are finding that having Supplier labeling in the Cloud is the best way to ensure compliance. […]

Pragmatyxs’ consultants and analysts

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Pragmatyxs’ consultants and analysts have been part of our organization for many years, enabling us to provide a thorough and high-quality customer experience for all customer engagements. Our consultants and analysts are experienced IT professionals allowing them to offer both technical and business perspectives for their projects. The benefit of seeking the help of our […]