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The currently used and industry sub-sector definition of an Ezi

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

ne is an electronic newsletter or electronic magazine that is s

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

Examples of combination products may in

nt out by email. But is this definition too limiting? There is

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

debate going on right now on this very subject; what is the tr

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

e definition of an Ezine and should this definition allow for i

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

Combination pro

novation and expansion?

It is believed by a small minority tha

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

it is unwise to too narrowly focus and try to corral naturally

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

evolving definitions. It is also believed that the definition o

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

an Ezine is still undergoing evolutionary change in the inform

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

tion age. We know that change is constant and that life and inf

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

rmation like water will always find a way to get to where it ne

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

Following aspects would a

ds to go. So, if we do such a cut and dry definition, we leave

dd to the challenges in developing combination products:

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

ther methods of distribution of the exact same material out to

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

ry with none.

For instance an electronic newsletter, which is

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

ent other than by email would not be considered an Ezine. Well

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

hen, what are they asked one enterprising industry guru? Are th

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

Professional from academic institutions, pharmaceutical industries, health care indust

y outside the definition and thus outcast and if so, does that

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

erve all of those who desire mass distribution. Do we try to fo

.

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

ce them into a definition by making them comply and send out th

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

Companies that provide selfless information through particip

ir Ezines via email? Perhaps we might 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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