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The problems linked with combination products evaluation: how to make the novel solution ready for recipients?

Because of the rapid development in many fields of life, new regulations have to be invented. Notably in the field of medicine, where the human well-being is the key factor, the products ought to be accurately tested before they enter the market.




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Author: pang yu liu
Source: http://www.flickr.com


More like a medicine or rather a device?


In case of some appliances it is quite challenging to proceed with all the regulations. For instance, combination product that consists of a device and a drug may be difficult to examine. It can be hard to specify which component plays the chief part in the resulting product: the medical (chemical) one or the device element. To assist in the final choice, a dedicated procedure was designed. Thanks to that, the producer can find out which office shall be contacted. Nowadays a wide range of appliances like that are being planned, so there is a big chance that something comparable has been invented in the past. This might make the choice simpler and in consequence, the assessment can be faster.


The future path of medicine


Drug-releasing stents or special wound plasters – combination products become a fact, not just a fantasy any more. They can enhance the standard of living for many chronically diseased people. But in order to achieve it, detailed evaluation is necessary. After all, the product must be sufficiently safe. Like any graft or drug that has a direct contact with organism, safety is the most important factor here.




When a given device passes all the tests, it could help with some issues that have not been easily curable before.

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The road is definitely full of obstacles, but the result is worth the struggle.