Cases - Business

In watching the Enron trial it appears to me that these gentlemen are going to get office Scott Free. Why is it t

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

hat our government is spending $200 million of taxpayers money all of this trial? Why not just give that $200 mi

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

Examples of combination products may in

lion back to those who lost all their pension when Enron closed their doors?

It seems as if the government lawye

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

rs are more concerned with the public relations problem on their hands if they fail to convict rather than the sh

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

ar amount of money they are spending that is taxpayers money. If the government doesn't care about spending our m

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

Combination pro

ney, they should pay be on trial them selves for fraudulently misrepresenting into misappropriating the taxpayers

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

monies? On one hand the government promises to convict these gentlemen to serve justice, yet in doing so they ar

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

making a mockery of the judicial system, as well as the Justice Department.

We should not let government lawyer

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

s for the Justice Department off the hook is easy. They are wasting our money in this trial has gone on for five

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

years almost six now and will not be over with appeals for another 2 1/2 years. If someone were to rob a bank or

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

a common man was to fraudulently steal money they would have been convicted and already have done over half of th

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

Following aspects would a

eir time in prison? So whereas I too demand justice, I also feel as though I have been lied to by the Justice Dep

dd to the challenges in developing combination products:

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

rtment, as it looks like they do not have a very good case.

It is amazing the amounts of interviews in the media

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

and the number of press releases hitting the AP wire that the Justice Department has put out. Truth justice and

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

he American way is part of a hallmark of this great nation into trash that by trying businessman in accord of pub

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

ic opinion at a time when Enron is so well-known that it is almost impossible for these gentlemen to get a fair t

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

Professional from academic institutions, pharmaceutical industries, health care indust

rial is appalling. Shame on the prosecuting team and the Justice Department for lying to the American people and

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

using public relations tactics to improve their case.

If the Justice Department has a good case then they have n

.

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

othing to worry about. Are we so sure that the prosecuting team is not running for public office like Elliot Spit

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

Companies that provide selfless information through particip

er? If the United States of America does not stand for justice, then may I ask; just what does America stand for

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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It is beneficial that you give a legal structure for any business venture that you may start as it helps establish credibility to your business and offers benefits such as limited liability protection. Incorporation is one of the options that new business ventures may choose.

Are you fond of using your credit card to make purchases in your favorite store? As far as you are concerned, the store cashier or your waiter just gets your credit card and swipes it on their little machine that produces a receipt for you to sign. At the end of the day, as long as there are no discrepancies with the statement of account produced by the credit card company and what you actually spent, you be at peace and you can rest easy.

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