Main Subject - Business

Any nonprofit group who has ever done a car wash fundraiser has probab

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

ly seen the local carwash owner drive-by and perhaps they wonder what

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

Examples of combination products may in

e was thinking. Well, having been in the carwash industry for 27 year

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

I can tell you exactly what he was thinking. He was considering that

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

you have stolen many customers on a very busy Saturday, which he could

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

Combination pro

ve made a lot of money off of.

He is also thinking that his carwash d

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

es a better job than your car wash fundraiser and that you do a disser

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

vice to the carwash industry by doing such lousy work. But the realit

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

of the matter is 50% of the people who go to car washes are not satis

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

ied with the carwash's job either. Carwash owners, whereas they like

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

o support the community, hate to see carwash fundraisers to take away

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

Following aspects would a

heir business.

Perhaps you cannot blame them. Nevertheless it is impe

dd to the challenges in developing combination products:

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

ative that your car wash fundraiser makes lots of money so your nonpro

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

it group only has to do one instead of several to earn the same amount

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

of money, which inevitably would upset the carwash even more.

If you

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

are concerned about upsetting the local carwash who also gives money t

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

Professional from academic institutions, pharmaceutical industries, health care indust

the local community then perhaps you might wish to hand out coupons f

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

r the carwash at your carwash fundraiser, as a nice thing to do. Simp

.

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

y go talk to the carwash advance and collect a handful coupons and giv

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

Companies that provide selfless information through particip

them to all the cars that come through. Please consider 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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