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Just Other Articles - Already Tired of the Holidays?
It seems to me when I was young, that the holiday season didn't start until after Thanksgiving. Not after the 4th of July. By September 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 I am so sick of hearing about what people are doing for the holidays, that I just don't care anymore. There doesn't seem to be any Ch ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ristmas spirit anymore. Oh sure, you see the occasional Nativity Scene, but even then it is only on church properties. What is wrong wi lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. th a symbol of the holiday being on public property? We recently had an incident here in Detroit, where someone complained about Christ here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe as trees at our airport being decorated. They apparently thought the Christmas tree was a symbol of the Christian religion and felt tha d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro t it was being shoved down their throat. So the trees, which were beautiful, were taken down, to appease this one person. What about th 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 e majority? Wasn't the Christmas tree started by a pagan group...not sure on that. But it bears thinking about....the Christmas tree is 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 NOT a religious symbol. I can almost understand the Nativity scene not being on public property...and before you get mad, remember I nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically aid almost...but have people forgotten what Christmas is all about? I remember as a kid, being excited about the Christmas holidays. A 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 ll the holiday decorations, not going up until after Thanksgiving. That was the start. You went out with your family at dusk to walk t ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi he neighborhood and see how everyone decorated their houses, you even took the time to stop at some of these houses to wish them a Happ ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a y Holiday season. It didn't matter if you were Catholic, Protestant, or Jewish. It was a time of rebirth for everyone. Now it is a time dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod of stress and going broke! Children now seem to have forgotten that Christmas is celebrating the Birth of Christ. Not Santa Claus and cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin his elves! It is a time of forgiveness and giving. Not the most expensive present you can think of. I worry about the future of Christ tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen mas and its true meaning. I worry about the people who have forgotten the spirit of Christmas. True, Christmas is primarily a Christian 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 holiday, but the spirit of Christmas..the one of forgiveness and love for your fellow man, regardless of race or religion..should stil ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust be practiced. There are people, not just children, all over the world starving, being tortured, living in the most deplorable conditi y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ons, while we sit here in what I truly feel is a wonderful nation, and worry about Christmas trees in a public place. Remind your chil . 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 dren and grandchildren why we celebrate Christmas. It is not a holiday for Christians only, but for everyone in the world to reflect on elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip peace and forgiveness. If we can do that maybe the future of the world will become brighter. Merry Christmas and Happy New Year to all 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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