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Why are you building a list? For fun or for profit? It is critica

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

l that you understand why you are building a list – you see, how yo

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

Examples of combination products may in

manage your list will be significantly different depending one the

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

purpose of your list.

So why are you building a list? This may se

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

m like a pointless question. You know you have to build a list bec

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

Combination pro

ause that is where the money is. Or at least that is what you have

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

eard. But you don’t really know it firsthand. You just know you s

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

ould be building a list, and you figure that once you build your li

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

t, you can make it profitable. But you have to take steps to make

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

it profitable, if it is going to become profitable.

But it doesn’t

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

really work that way. You see, you need to know why you want your

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

Following aspects would a

ist. Who are you going to put on your list? Are they going to be

dd to the challenges in developing combination products:

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

uyers or freebie seekers, are they going to simply read your emails

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

and yawn or are they going to click through to sales pages and spe

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

d their money? What types of products are they going to want to bu

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

? Why are they going to open your emails?

All of those questions,

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

Professional from academic institutions, pharmaceutical industries, health care indust

and especially the answers to them, are critically important. If y

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

ou build the wrong list for your product or your purchase, you will

.

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

not be able to make it profitable. So you have to decide why you a

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

Companies that provide selfless information through particip

e building a list, and then build it in accordance with those goals

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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