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Useful Advices - Everybody Wants To Raid The Barn - Nobody Wants To Plant The Corn
I was visiting my friend Mitch the other day - he is one of the owners of Visio 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 n Tech Computers here in Fort Wayne - and we had a little chat. Mitch told me s ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in metimes his customers (sometimes friends and relatives) would call him even aft lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. er 11pm to ask him about a computer challenge and now, he has to turn off the p here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe one after 11pm on most days. Unfortunately he does not get paid for advice that d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro he provides. My grandfather, a successful entrepreneur, used to say "T 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 he people who regularly provide or receive advice without getting compensated a 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 e both fools." I believe he was not against helping people or sharing nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically information when necessary, because all his life he was involved in charity wo 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 k pretty much every day. I believe he was talking about the "I would like to pi ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi k your brain for free" people and folks who do not value others’ time because t ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a heir own time is not worth that much. Not just Mitch but even I fall i dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod to this trap because most of us like the high we get from helping someone or sh cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin aring something we just discovered - especially in technology. In other cases w tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen just don't like to say "NO" to someone we know well. What we don't re 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 lize is the missed billable time not serving paying customers or the advice we ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust give is not valued besides all the received compliments. Something that I also y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products otice is in most cases the people who would receive free business advice don't . 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 do anything with it because they know "what they paid" for it. The bott elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip m line is “what is not measured is not treasured." InfoGuru2K6 © 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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