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One issue that just burns up most American taxpayers is the money we spend loc

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

king up our prisoners and criminals. They want the Televisions and weight room

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

Examples of combination products may in

s removed forever. And recently in an online think tank a think tanker stated:

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

“Inmates are constantly punished, every day in every way - denied medical ca

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

e, and their "color" TV is ONE in a common area that doesn't come in well (rec

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

Combination pro

eption).”

However this notion was immediately challenged by another think tan

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

k member who stated: “Half of all Americans do not have health care and I pers

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

onally have never been to a hospital in 25 years or to visit the doctor and I

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

m fine?”

Indeed one has to ask why should the taxpayer pay for health care fo

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

r those who are not producing for society and even basically told the society;

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

“screw you!” and decided not to follow the rules. Why should they get any hea

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

Following aspects would a

lth care? Why not use some of these more harsh criminals for animal testing? T

dd to the challenges in developing combination products:

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

ey are animals? As long as they do not have the double chromosome, they can be

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

used for testing?

The most liberal think tanker stated; “The 3 meals/day con

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

sist of mystery meat, barely edible vegetables and if they are lucky, they may

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

get one piece of fruit (usually not ripe) a quarter.”

What are you saying he

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

Professional from academic institutions, pharmaceutical industries, health care indust

e? You want gourmet food? Put them on the front lines in Iraq dodging roadside

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

bombs and then maybe they can get a good meal for an honest days pay. Shouldn

.

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

’t we be serving the citizen and taxpayer before the criminals who have decide

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

Companies that provide selfless information through particip

d they do not have to follow the rules? Shouldn’t we 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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