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Apart from the standard domains such as .com, .org, and .net, a number of other domains appear to be advertised world wide or in select localities that are

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

not always what they seem to be.

Of course there are all of the standard country code domains that have been allocated to each country of the world for the

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

Examples of combination products may in

r own exclusive use. Some of the smaller countries have decided to raise money by selling the use of their domain for more general purposes or for specific

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

purposes other than what was intended when the domain was allocated to them. The original purpose of the domain was to provide country specific sub-domains

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

o residents of the country concerned. As the domain has been sold for other purposes, it is of course not available for its original purpose. There is howev

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

Combination pro

r nothing to stop a new government in any of those countries from deciding to recover the domain for its original purpose and anyone who has purchased a sub

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

-domain in one of these domains would then find themselves having to change the address of their web site.

Examples of domains where this applies include .

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

c (Cocos Keeling Islands), .cx (Christmas Island), .la (Laos), and .tv (Tuvala). Should you aquire a sub-domain in these or any of the other country domains

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

that have been made available for a different use than originally intended then you need to be aware that you may lose the sub-domain should the country con

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

cerned change their mind about how their domain will be used.

Even worse than the above are "domains" issued by private companies. The official list of dom

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

ins including the .com, .edu, .net, .org, etc. the country specific domains, and a number of new domains that are just starting up (eg. .biz and .info) are

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

Following aspects would a

ssued by an international body responsible for control of naming on the internet. These domains are registered with the master address tables on the net and

dd to the challenges in developing combination products:

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

are therefore accessible to everyone with internet access. "Domains" issued by private companies are not loaded in these master lookup tables and require t

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

e addition of a plug-in module usually at each ISP (or on each individual computer where the ISP hasn't installed the plug-in) in order that such domains be

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

able to be translated into addresses. This means that only those internet users using such ISPs as have installed the appropriate plug-in have access to the

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

se "domains". Also, as these are issued by a private company, you are relying on the continued operation of that company for the continued existance of your

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

domain name. One example of a company selling such "domains" is New.net who have issued many such domains eg. .shop, .xxx

I am not by any means suggesting

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

hat you should not go ahead and purchase a sub-domain of any of the domains that I have mentioned (or any of the many othe similar ones). All that I am sugg

.

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

esting is that you do a little research prior to your sub-domain purchase so that you know exactly where you stand. The benefits to you of having one of the

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e domains rather than one of the more usual ones may by far outway the possible future problems that such a choice may have. The final decision is up to you

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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