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Delicious - Where is Your Brother?
The story of Cain and Abel stands very close to 21st century man. For who cannot be exposed to the prevalen 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 ce of murderous crimes existing in our society and world without occasionally reflecting back upon the firs ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in t murder? The narrative of these brothers is symbolic of the relationship between God and man and between m lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. an and his brother. Read about the history of God’s dealings with man in your Bible and you will notice tha here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe t God always intervenes. And I am not referring only to physical murder for we know that we can commit mur d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro der in subtler ways than the physical. Perhaps the mordant lines of Oscar Wilde make this point clearer. Y 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 et each man kills the thing he loves From all let this be heard Some does it with a bitter look 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 Some with a flattering word The coward does it with a kiss The brave man with the sword. nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically There are other ways of murder than the physical. We can kill others’ joy, their spirit, their devotion, t 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 heir will, their motivation. Whenever we commit a crime, in any of its many shapes, against our neighbor, G ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi od wants to know, “Where is your brother?” To Adam and Eve, after they had eaten from the forbidden tree a ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a nd attempted to hide, God asked, “Where are you?” To Elijah, when he fled to Beer-sheba to escape Jezebel, dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod God found him and asked, “What are you doing here?” To Job, when he began to erratically question the sen cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin sibility of his existence, God asked, “Where were you when I laid the foundation of the earth?” To Cain, a tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen fter he killed Abel, God asked, “Where is your brother” When Cain had done his worst to Abel, he could not 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 get away from God and neither can you; neither can I. God always confronts us. He confronts us in our nake ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust dness, in our ugliness, at our weakest point. In spite of how it may seem, sooner or later man must recogn y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ize that any cruelty to any human being brings us face to face with the judgment of God. Even though it may . 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 seem that criminals are getting away, rest assured that when we reach the dead-end streets of our lives, G elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip od will meet us there and He will want to know, “Where is your brother?” The voice of God cannot be escaped 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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