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Even though we live in different countries, speak different languages, have dif 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 ferent cultures and look different from each other we must come to the realizat ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in on that we are all living on this spaceship we call earth. It is easy to forget lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. the fact that we are linked together closer than ever -- with air travel making here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe almost anywhere a matter of hours or days from our doorstep. Whether you live i d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro the United States, China, Iraq or Iceland we all share our home --the earth. 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 ealth and poverty seem to be where we would prefer to be separated. Cheap impor 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 s from countries like China and Indonesia allow those in "first world" countrie nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically keep more of their money for more material wealth. However, as there is a glob 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 l shift occurring -- whereby the higher paid manufacturing jobs are being expor ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ed to places that can do the same job much cheaper -- what is left is service i ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a dustry jobs that offer less pay and benefits. Some people consider themselves dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod ich if their family is healthy and happy. Others, and i'm thinking this include cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin more people than we would wish to admit, are not happy with what they have. Th tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen se people are only happy (and this feeling is almost always fleeting) when they 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 are about to buy or have just bought something they desire. At some point we w ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ll have to come to the realization that the earth itself is far more important y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products han we thought in the past. We will have to be kinder to it.
We will also have . 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 to come to the realization that we need to share more with others, "you know, l elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ke we were told to do when we were children, but somehow forgot as we got older 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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