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E-Folder - Beware the Chicken Little Consultant
Paying for expertise is an inherent part of business. How else can we make the best decisi 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 ons in specialty areas without informed help? Unfortunately there can be conflicts of int ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in rest on the part of your expert which can be subtle yet extremely powerful. Ask yourself lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. one question: Would your consultant benefit by prolonging your issue or project? If the an here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe wer is yes, you may be paying more than you should. Paid experts have the power to prolon d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro g an issue or project thereby stuffing their pockets with more of your money, simply throu 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 h their presentation style. If you have a Chicken Little consultant, fire him or her immed 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 iately. For those to whom Chicken Little is unknown or a fog in the distance, here's the nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically coop: Chicken Little is a storybook character who would periodically run about crying, "Th 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 e sky is falling, the sky is falling!" The townspeople were initially frightened and woul ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi run for cover similar to how our government expects us to, when one of their multi-colore ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a d alerts are issued. After a while they realized that Chicken Little was really a turkey dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod the disparaging term type - and came to ignore him. Miraculously, after they completely cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin tuned him out, he actually had something important to say. Needless to say, they ignored h tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen m and got creamed. Now we come to your paid expert. Does he try to prey on your insecurit 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 ies? Does he disparage everyone but himself? Does he present his ideas with emotionalism r ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ther than researched fact? If the answers are yes, save yourself a bundle and get a new co y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products nsultant. Better yet, take some time to study the subject yourself. The internet and a go . 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 d search engine is the best consultant you will ever have. If some sites utilize scare tac elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip tics, there will be plenty of others to balance the message. Copyright 2005 www.poingo.co 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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