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There appears to be some serious debate these days as to what an Ezine is. Most people simply

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

call it an Electronic Magazine and in fact this is the definition that appears in the back o

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

Examples of combination products may in

many Books and eBooks on the subject.

Unfortunately electronic magazine is too simple a def

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

nition and many people believe and Ezine is a newsletter or magazine, which is sent out via e

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

ail. You can see how this debate got started and how those who specialize in Ezine Publishing

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

Combination pro

or distribute content to Ezines are concerned about it.

Nevertheless, I think absolute defin

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

tions are not smart to use because the Ezine Format is still evolving. Some Ezines are in bot

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

Print and Electronic. Some are sent by email, or on a computer system and then printed and d

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

stributed. Some are printed, scanned and then emailed.

So in this case a Printed Work become

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

an Ezine when it is mass sent by email even if at the time it may not have been intended dur

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

ng its creation to be distributed in such fashion. It makes sense to be careful with definiti

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

Following aspects would a

ns otherwise you box yourself in and miss a potential opportunity in the future as things evo

dd to the challenges in developing combination products:

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

ve.

Meanwhile many folks post what they call Ezines on their companies computer networks for

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

those vendors, employees and departments which use a specific intranet system. Even though th

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

y call their electronic newsletters and magazines Ezines, they do not fit the most used curre

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

t definition of the word, as it is used in the real world.

Many Printed Magazines have weekl

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

Professional from academic institutions, pharmaceutical industries, health care indust

updates, but do not call their weekly newsletters Ezines, as to not detract from their mains

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

ay or printed version. So, the highly controversial debate rages on.

No matter if you are pr

.

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

nt publisher, editor or writer or an electronic publisher, editor or writer, chances are with

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

Companies that provide selfless information through particip

all the cross-overs the definition is much wider than once thought. 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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