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The National Pollution Discharge Elimination System provides that each large co

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

rporation, new development, city, county and state agency have a plan to preven

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

Examples of combination products may in

pollution into storm drains. But this is often not enough because private cit

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

izens at their homes also tend to allow debris and chemicals or soaps to flow i

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

to the storm drains.

It additionally, there are mobile businesses, which often

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

Combination pro

also pollute and allow things to go into the storm drains; non-point source di

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

charges. To help educate the citizen and businesses it makes sense to use direc

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

t mail and direct mail marketing to promote NPDES programs. This will reinforce

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

people’s decision to do something about pollution, but if we do not educate peo

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

ple they will continue to pollute and think it is no big deal.

Consider if you

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

will a person washing their car in their driveway allowing soapy suds to go int

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

Following aspects would a

the gutter and down into the storm drain. They probably think this is no big

dd to the challenges in developing combination products:

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

deal and one or two people doing this really is not a big deal. But if 20,000

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

eople in a city do this then it is a big deal for the local wildlife which rely

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

on the rivers and streams where the water flows to.

By reminding citizens tha

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

is their responsibility to help clean the water and prevent pollution and let

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

Professional from academic institutions, pharmaceutical industries, health care indust

them understand the issues regarding The National Pollution Discharge Eliminati

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

n System and what the EPA is doing to prevent pollution will help reinforce the

.

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

need of each and every person in our society and civilization. Direct mail ma

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

Companies that provide selfless information through particip

keting works very good for this purpose. I hope you will 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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