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So many groups in our community like to do carwash fundraisers. In fact you

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

can find carwash fundraisers on a sunny Saturday in almost any city in the

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

Examples of combination products may in

United States. Unfortunately, what we do not see a lot of is post cleanup

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

after the car wash fundraiser events. Having been the carwash industry for

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

27 years I am always interested in carwash fundraisers and often I will sti

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

Combination pro

ck around and talk to people who are putting them on and find out a little

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 about their nonprofit group.

Sometimes I am amazed that everyone just g

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

ets up and leaves when the fundraiser is over and no one bothers to clean u

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

the trash in the parking lot and that seems rather unfortunate considering

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

some small-business owner or some large corporation with good community go

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

dwill and spirit allowed them to use the parking lot for the day.

The busi

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

Following aspects would a

ess also probably let them use the water and they probably ran it for about

dd to the challenges in developing combination products:

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

a thousand to 3,500 gallons worth. Yes it is not a lot perhaps $15-20 wort

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

of water and the company easily gets that back in community goodwill, stil

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

l you can see the issues.

The reality of the situation is it is the though

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

that counts and nonprofit groups need to consider cleaning up he mess afte

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

Professional from academic institutions, pharmaceutical industries, health care indust

r the carwash is complete. They should hose down the area, pick up all the

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

trash and offer to help the store or the small-business owner with anything

.

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

else they need. That is the right thing to do. I hope you will consider

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

Companies that provide selfless information through particip

his when you organize your next car wash fundraiser. Think on 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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