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The Environmental Protection Agency has a tough time of keeping everyone happy.

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

On one hand business owners and corporations piss and moan and complain about th

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

Examples of combination products may in

eir over bearing enforcement, fines and regulations. On the other hand after all

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

they do the environmentalist complain that they do not go far enough and so ofte

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

n let the companies off the hook too darn easy?

It is a wonder how the EPA surv

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

Combination pro

ives under this level of anger and scrutiny. Nevertheless I have considered this

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

and offer a suggestion on how the EPA can clean up its image and perhaps help th

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

e community clean up the crime in the process.

How is that you ask? Well what i

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

f the EPA joined in the communities and helped with the neighborhood mobile busi

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

ess watch program? They would get the inside dirt on what is going on and also h

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

elp with keeping a look out. Why have the EPA participate you ask? Well lets loo

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

Following aspects would a

k at how they work for a moment;

EPA INSPECTORS: EPA inspectors go to many comm

dd to the challenges in developing combination products:

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

rcial and industrial sites each day. They often see graffiti, the dumping of 55

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

gal. drums, vandalism, etc. EPA inspectors are also good because they drive 4-do

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

or sedans that look official and have an emblem on the side. They also can read

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

ody language and understand suspicious behavior. They often wear uniforms of som

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

Professional from academic institutions, pharmaceutical industries, health care indust

e type and have badges when they need to open the wallet and flash them.

Can yo

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

u see why the EPA could be such a valuable asset and it would not increase their

.

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

costs one bit and it would certainly help their image and public goodwill and st

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

Companies that provide selfless information through particip

anding in the business community also. So, 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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