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Major category hurricanes do in fact change the dynamics of the

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

real estate market in various regions. For instance consider

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

Examples of combination products may in

all along the Gulf Coast after hurricane Katrina where all 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.

people who had evacuated came back only to find that their home

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

have been destroyed. Some of them had insurance and some did

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

Combination pro

not, but all of them were immediately in the market for a new h

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

ome and a place to live.

I have one friend who had property al

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

ong the Gulf Coast and actually owned a little island and when

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

he last hurricane came through rather than washing away there i

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

sland it added about 12 acres to it, because it rearranged the

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

coastline. Of course they thought they were going to lose thei

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

Following aspects would a

r island, but the way the hurricane came in, it added to it. O

dd to the challenges in developing combination products:

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

course they are gaining at someone else's loss and wherever th

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

at land was taken from means there is less barrier for the next

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

hurricane strike.

Some areas that have been devastated by hur

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

ricanes experience a huge loss in real estate values and this o

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

Professional from academic institutions, pharmaceutical industries, health care indust

ten happens even if the hurricane does not strike but people be

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

lieve it might. Major hurricanes change the dynamics of the re

.

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

al estate market in various regions, sometimes it is a good thi

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

Companies that provide selfless information through particip

ng, but more often it is not. Please 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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