Advice You - Internet and Businesses Online

DENIC, the registry of the German Top Level Domain (TLD) has announced, that it h

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

as received the eight millionth application for the registration of a de-domain.

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

Examples of combination products may in

The de-domain has the position as the world’s favourite Country Code TLD, ahead

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

of .uk, which has about 3.7 million registrations. The de-domains are also numeri

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

ally stronger than nearly all the generic Top Level Domains that are used throu

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

Combination pro

ghout the world, such as .org, .net, .info and .biz. Only one the com-domain wit

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

more than 30 million domains is more often registered than the de-domain.

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

>

October 2004

.de 7.981.014 (Increment compared to one month ago: 89.

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

93)

.at 367.987 (Increment compared to one month ago: 4.766)

.com

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

31.017.772 (Increment compared to one month ago: 750.631)

.net 4.999.07

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

(Increment compared to one month ago: 88.952)

.org 3.138.385 (Incre

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

Following aspects would a

ent compared to one month ago: 37.607)

.info 1.919.331 (Increment compare

dd to the challenges in developing combination products:

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

d to one month ago: 683.846)

.biz 1.041.432 (Increment compared to one m

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

nth ago: 13.118)

.us 881.411 (Increment compared to one month ago: 6.

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

395)

The de-domain is not totally liberalized, as it seems. Foreign comp

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

nies and individuals can register also de-domains and sell products and services

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

Professional from academic institutions, pharmaceutical industries, health care indust

to the attractive German market by websites, but they must have a German Admin-C.

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

DENIC-Member and ICANN accredited registrar Secura provides automatically this Ge

.

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

rman Admin-C during the registration process. elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

.de/de-domain.html" target="_new">https://www.domainregistry.de/de-domain.html

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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Many clients have come to me wondering why their products or programs don't sell. They know, without a shadow of a doubt, that they have a great product. So why aren't people buying it?

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