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One of the easiest ways to get citizens to rebel against their government is to over

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

tax them. It should be noted that tax revolts or overbearing government has caused

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

Examples of combination products may in

ore than one overthrow of said governments. When the British overstepped their boun

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

aries on the American colonies and overtaxed them we had the Boston tea party.

This

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

led others to eventually revolt and if it were not for the British overtaxing the co

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

Combination pro

onies and treating them poorly the United States still might be part of Great Britai

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

n today. In fact this might go down as one of the biggest mistakes in history. In I

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

dia, a similar situation took place on the over taxation of salt and this caused man

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

who were upset to take a 170 mile march to the sea for salt and boil salt water to

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

et their own salt, thus by-passing the tax; one of Ghandi's brilliant political stra

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

egies, the salt protests in India.

Today the high price of oil in the US means high

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

Following aspects would a

er taxes that we pay on the fuel we buy. The high tax of oil is causing pain for the

dd to the challenges in developing combination products:

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

US citizen and if in the future we all vote for universal health care then the gover

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

ment will have to raise taxes in order to afford it. The health-care system in the U

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

ited States is already broken and if some legislation of this nature passes than tax

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

s will skyrocket. What does that lead too? Come folks study some history.

Remember

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

Professional from academic institutions, pharmaceutical industries, health care indust

when over taxation on a society where civilization gets too high you can expect civi

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

unrest and perhaps even a revolution or revolts against the government. Is it funn

.

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

how history repeats itself? I hope you are looking at the future of this situation

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

Companies that provide selfless information through particip

as it is rather interesting and somewhat intriguing that no one is talking about it

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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A discussion about the poor management that has brought Ford to where it is now.

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Answers - Tax on Tea, Tax on Salt or Tax on Oil - Will They Ever Learn

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