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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

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; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

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lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

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here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

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d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

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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

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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

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nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

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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

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ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

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ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

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dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

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cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

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What would be the developing cost?
How to tackle the risks encountered during combination product developmen

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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

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y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

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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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