Main Subject - Business

Water erosion is a huge issue along our coastlines and it is also

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

a big concern in many areas with rivers, lakes and in places with

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

Examples of combination products may in

eak run-off periods during the year. Water erosion causes bridges

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

o fail, roadways to have sinkholes and severe issues with run away

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

rivers over spilling their banks.

The problems can get so serious

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

Combination pro

that many areas have specially trained swift water rescue units i

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

case of such a disastrous problem. Nevertheless folks still often

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

just do not get it and it makes sense to alert people to the real

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

roblems of water erosion and how to deal with it, as well as the p

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

otential dangers. This can be done thru a robust public relations

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

rogram so that people will trust this information as it generates

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

Following aspects would a

ocal community goodwill.

Information can be posted around town at

dd to the challenges in developing combination products:

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

libraries, city hall and perhaps even mailed to folks in 100-year

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

flood zones as well. Too often in the news we see that folks have

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

een flooded out from their homes due to a river embankment failing

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

a mudslide or a cliff giving way.

If water erosion public relati

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

Professional from academic institutions, pharmaceutical industries, health care indust

ns programs were done in advance to alert and educate the local ci

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

tizens of the area many of these things would never occur. A litt

.

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

e advance warning and education strategy in the local media could

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

Companies that provide selfless information through particip

lleviate many of these concerns. 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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Main Subject - Public Relations for Water Erosion

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