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Top Adding - The Ship is Sinking-Throw the Debt Overboard
Are you taking on water, are the debt collectors calling? Did every credit card you have get declined at dinner tonight? Hey join th 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 e growing club, they are making prime time shows on taking people from the brink of bankruptcy back to financial health. You know wh ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in n it is a TV show that it is just that common of a thing. It was not always this way. In post WW II people were sailing pretty lean lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. and mean ships. They did not buy anything they really did not need. My Grandpa (and likely yours also) talked about the ‘hard time’ here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe nd that really made that generation “penny pinchers”. Those days seem long ago. Now we have the most ‘bling-bling’ sailing vessels i d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro the history of the world. Many of these boats are sinking and fast. Are you in one of them? If you are not, the percentage says yo 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 ur neighbors on your left and right, are. Amazing isn’t it, the Joneses are one paycheck away from losing it all. Heck many families 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 are less than one paycheck away. What to do, just like in the old days, throw stuff overboard. The fancy leased car, get rid of it. nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically Of the most common purchases, buying or worse leasing a fancy car is one of the worst, why? It loses money year after year. One of m 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 friends (who by the way is struggling with debt) drives a leased car that costs as much as the mortgage on my first home. That is i ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi sane considering he'll never own it. It seems that when it comes to vehicles we lose our ability for sound judgment. I know a 1967 ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a Mustang is, for some unbelievable reason, worth several hundred thousand dollars. Trust me that will not last and I would like to me dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod t the person who paid $300K for a $3000 car. Aside from the present insanity for muscle cars, cars just plain lose you money. Get so cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ething economical and easy to maintain. Eating out, coffee, smoking, magazines, cell phones (if yours does not make you money), new tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen cloths, furniture, jewelry and the other million things you just “have to have” stop buying them because they are causing links in y 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 ur financial vessel. Getting rich is just so easy if you will spend less than you make. It is like a restaurant guy I knew, he woul ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust d say we lose a bit of money on each sale but we are going to make it up on volume. As crazy as it sounds many people actually think y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products this way. Of course they go broke and their ship sinks. Stop and have a look around you, how is your financial situation? Really st . 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 p and have a good look, now look backwards ten years. How was it then? Has it changed much? Draw a financial line from then to now a elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip d off into the future, how does it look? Did you just chart a path into the rocks? If so take action and get your ship lean and mean 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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