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Does it make sense to keep a transportation system like Amtrak whi

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

ch loses money each year and costs the taxpayer’s millions of doll

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

Examples of combination products may in

rs? A transportation system, which is not only inefficient, but al

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 unreliable and an international terrorist target to boot? Why wo

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

ld any government or civilization accept such a thing? Amtrak is a

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

Combination pro

complete waste of the taxpayer’s money, but since it is looked on

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

a social services pet project we cannot get the liberal Senators t

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

remove its burden.

The only way Amtrak could become efficient is

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

to turn it over to private enterprise once and for all. When the

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

Canadians turned over part of their Government owned train system,

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

which was similar to Amtrak model, it not only had better on time

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

Following aspects would a

ervice, but it started making a profit too. Can you believe it? Th

dd to the challenges in developing combination products:

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

s should not surprise anyone, because no matter whose government w

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

e are talking about; government agencies can never do anything ver

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

well.

Is it fair to over charge the taxpayers for Amtrak and the

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

deliver half-baked service to those who ride the train? Is it rig

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

Professional from academic institutions, pharmaceutical industries, health care indust

t to have a system which is an international terrorist magnet like

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

that rolling down the tracks until a fateful day? Has anyone real

.

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

y looked at the Amtrak in a reasonable and rational way and if so,

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

Companies that provide selfless information through particip

then why is no one listening to reality? 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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