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Advice Pool - Newlyweds - Are Your Gifts Protected?
Picture the day; you’ve been planning the event for months if not years and your wedding turns out to 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 be wonderful (if the infamous British weather behaves). The day goes flawlessly, the kiss of the sun ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in and gentle summer breeze brushing against your skin are enchanting. You receive countless wonderful g lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. fts and you make your way through your guests thanking them (or add a mental note to thank them at a l here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ater date), then like a record becoming stuck you hit a snag and you’re flung back to reality with a b d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro mp. “Will my gifts be covered?” you ask yourself, thinking back to your recently purchased home insur 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 ance policy on the house you are to share. This may not be the small fleeting thought that it at firs 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 t appears to be. It is a worrying fact, highlighted in a recent report undertaken by Churchills, that nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically you may not be covered for some or all of these gifts under your policy. With the average gift settin 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 g a guest back ?60, this could quickly add up to a large sum of money and no laughing matter. The pro ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi lem is, an amount maybe as large as ?3000 or more, may leave an equally large gap in contents insuranc ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a e. With the average wedding guest bringing such gifts as, fine china and glassware, cutlery and furni dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod shings, to name but a few, these items may not be covered under your house insurance policy. Luckily cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin or some of you, certain insurance companies offer a temporary cover around the time of your wedding co tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen vering you for such eventualities. The moral of this story is; don’t let your wedding day be ruined b 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 thoughts of protection for your “expensive” gifts (although in actuality this may be the last thing o ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust n your mind). Check with your policy issuer that your items will be covered, if needs be use your wed y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ding gift list as a handy list of possible contents. With this issue dealt with, you can breathe a si . 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 h of relief and cast your mind back to the wonderful day you’re going to have. Don’t forget to cross elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip your fingers and pray for that British weather to hold out and you never know, you might just be lucky 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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