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Advice You - Made in Our 53rd State
A few months ago, I was given a bar of soap from a very well know high-end chain store. The person who gave me the soap knew I worked According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product with this type of product and wanted to give something she thought I’d like. I looked at product, liked color and fragrance, put it on ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in a shelf, and honestly forgot about it. The other day, needing a new bar of soap, I found the bar and decided to use it. Reading the lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. back, it gave the name of the company with their motto, “From the Heartland of America.” The very next line read, “made in Guatemala.” here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe So when, may I ask, did Guatemala become a “State?” And, on top of that, once I took the clear wrap off, I was disappointed in the s d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro oap itself. To anyone who has used M&P, you will understand. To all others M&P means Melt & Pour. You go to your local craft store, ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc buy a base, heat it up and pour into molds of choice. Nice way to have decorative soap without the hassle and having lye around the ho easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi se. So, this soap looked like someone had used M&P, added color and fragrance. Because it came from this well know chain, I was curio nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically us about what the cost was and decided to go to my local mall to check out the price for myself. $8.00 a bar, only one word for that, and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ RIP-Off! OK, so that’s two, but who’s counting. Now, please don’t get me wrong, I’m all for fair trade, but to say the product is fro ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi m the heartland of America, than have the very next line read “Made in…….,” sounds a little false advertising to me. Company headquart ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a ers, yep, in the heartland of America, but Guatemala? Maybe my sense of geography is playing tricks on me. Last time I looked at my dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod map of the world Guatemala was in Central America, or have we annexed it, so that it is a protectorate like Puerto Rico and Guam? If s cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin o, then yes, it can then say, “Made in America,” or for that matter from any region of this great country. But, maybe I’ve read it wro tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen g, they were on two separate lines. Just maybe in my old age, I’m beginning to run words together. But to read From the Heartland of t? As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel American, then to read Made in Guatemala, simply does not ring true. Producing products outside of the USA, may save companies money b ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust y paying less for wages, but why not pass that savings to the consumer. If they can give retiring executives retirement packages worth y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products millions, why not give a little back to the average buyer. High-end products are nice, but when money is running low, guess I will no . As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de t be going to the mall for my soap. The best soap I’ve used has been made by a friend, the old fashioned way. In fact, my son swears b elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip y her Goat’s Milk Soap. Since “made in …..” has become our 53rd state, wonder if I can save money but shopping there? Copyrighted 200 tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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