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When owning a domain name the owner is required to submit certain data about himself to complete the

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

registration. Name and address information as well as a phone number and an email address are requi

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

Examples of combination products may in

ed to be on file. If these pieces of information are not provided the registration can either not be

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

completed or is not valid and the domain name could be taken away.

Often people forget to keep thi

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

information updated. This is not a dramatic issue until the domain name expires and needs to be ren

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

Combination pro

ewed. If the owner keeps track of the names it is no problem, but too often people tend to forget. E

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

ail reminders are usually send out by all domain registries. But what happens if the email addresses

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

associated with the domain name are no longer in use? The domain name expiration notification canno

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

be delivered and the name expires.

What happens when a domain expires?

When a domain expires it w

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

ill remain in this status for approximately 30 days. During that time the DNS servers of the expired

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

domain will be reset to the domain name registry and the website behind that domain name is down. If

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

Following aspects would a

the domain name does not get renewed during 30 day time frame, it will be deleted from the domain r

dd to the challenges in developing combination products:

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

gistry database and at that time the domain will go into Redemption status at the Registry level. T

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

he domain name is still recoverable, but only for a significant amount of money. After around 40 day

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

the domain name gets deleted and released and is available for a new registration. Domain Grabbers

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

pick up these expired names and sell them with a profit to whoever pays the most money. If an owner

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

Professional from academic institutions, pharmaceutical industries, health care indust

appens to lose a domain name by forgetting about renewing the name and by not acting fast enough whe

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

n the name is expired, it can mean that the name cannot be recovered by him and that the name belong

.

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

to somebody else now.

Therefore it is highly critical to always maintain correct WHOIS data for a

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

Companies that provide selfless information through particip

domain name and to keep track of expiration dates to renew domain names in an appropriate time frame

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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