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An Ezine is an Electronic Magazine that you can receive in your email in

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

box. That is the pure definition, although there is some debate as to wh

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

Examples of combination products may in

at is an Ezine and what is an online newsletter. Most believe that an Ez

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

ine is a Magazine in Electronic form and those who made up the word sure

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

ly believed that, but today this definition is evolving and some are arg

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

Combination pro

uing over what an Ezine really is?

In fact from a pure usage standpoint

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

of those who gather their news and information and prefer this format,

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

I would say that Ezine does not suffice and needs an upgrade of the defi

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

nition. Additionally an online newsletter or update with multiple storie

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

s or information and graphics is an Ezine, I beg to differ with anyone w

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

ho denies that. In fact if it is not, then you better go 70% of those ou

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

Following aspects would a

t there that call them selves Ezines, because they are running away with

dd to the challenges in developing combination products:

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

the show and many have HUGE subscription bases in the 10s of thousands.

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

The definition of Ezines is evolving and attempting to limit the defin

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

ition, perhaps does not serve the users or subscribers. More importantly

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

the quality of the Ezine is at stake because of the shear numbers of ne

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

Professional from academic institutions, pharmaceutical industries, health care indust

w entrants into the market and the ways they attempt to differentiate th

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

emselves. This is an interesting subject and I wonder how many others ha

.

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

ve opinions or thoughts on alternative definitions out there and how man

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

Companies that provide selfless information through particip

y definitions maybe introduced in the future. Consider all this in 2006.

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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