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Top Reference - There is Power in Believing
I once read a story about a Catholic priest who was a godly person. He was so godly that when he died people believed that his bones had 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 healing powers. People would line up for days just to touch his bones because they believed that by touching his bones they would be c ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ured of all aliments that were plaguing them. And, sure enough, day-by-day, miracles were happening--people were being healed by touchi lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ng this guy’s bones. One day, the priest came in and discovered that someone had broken into the church and stolen the bones. Yup! Sto here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe le them. Because people were always waiting on line to touch these miracle bones, there were tons of people already lined up outside, w d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro aiting. The priests were afraid that if they delivered the news that the bones were missing, the people would riot. So, instead of caus 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 ing a riot, what they decided to do was to tell the police about the stolen bones, ask them to make finding the bones top priority and t 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 o keep it quiet -- not let the word get out because they didn’t want the people to start rioting in the streets. The way the priest fig nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ured it was, in a few days, the police will have the bones back in its place and in the meantime, they would use somebody else’s bones. 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 The problem is, the only bones they had were the bones of a thief. But hey, who would know the difference? Yes, people wouldn’t be heale ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi d for a few days while the police locate the “miracle” bones, but that was better than having a riot on their hands. So, they dug up bo ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a nes and used those bones in place of the “miracle” bones. The priest nervously looked on as people piled in to get healed by touching t dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod hese bones. And guess what? People were being healed. People were touching the bones of a thief and were being healed. How could thi cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin s be? Because it didn’t matter WHAT bones were there because there was no magic or miracle power in those bones. The power is in belie tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ving. In Matthew 21:22, Jesus states: “And all things, whatsoever ye shall ask in prayer, believing, ye shall receive.” Whatever you a 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 sk for, AND BELIEVE, you shall receive. Because those people BELIEVED that by touching those bones they would be healed, they were heal ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ed. The power is in believing. If it weren’t true, Jesus wouldn’t have said it. So, when you say, “Oh, I’ve been praying for such and y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products such and God isn’t hearing my prayers.” It’s not that he’s not hearing your prayers, it’s that YOU do not believe that you will receiv . 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 e whatever it is that you are asking for. God hears our hearts and give us whatever we believe. There’s power in believing. Develop yo elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ur belief system and you will see miracles happening in your life. Whatever you ask for in prayer, AND BELIEVE, shall be given unto you 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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