Main Subject - Business

Having been involved in business and politics and watched government attack us busines

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

s folk and thus having been on all sides of this equation, it is readily apparent to m

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

Examples of combination products may in

e that the humans are just doing what humans do anyway. Humans are inherently problema

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

tic, often very deceptive and not such honest beings in general.

If we thrust the hum

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

an animal into a modern civilization and the system does not take into consideration h

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

Combination pro

uman nature it will not be fair and no one should expect it to be. Yet, if we will all

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

step back from the situation and look at what we really have going here we will see w

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

hat needs to be done and then we can start from there.

You see, as it stands now; Pro

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

secutors often have political ambitions and judgeships are a political event. Lawmaker

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

s have interests in remaining in power and need money to do so and adjust the laws for

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

lobbyists with special interest. Lawyers make money by hijacking the law. Cops have I

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

Following aspects would a

Q of under 103 or they are not allowed to be police and one-third are criminals themse

dd to the challenges in developing combination products:

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

lves hiding in broad daylight as protectors of peace? Every criminal I have ever met s

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

ays they are innocent and every victim I meet wants revenge. So all this is human natu

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

re. The system is not taking all this into consideration.

So instead of fixing it all

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

, we make more laws, more complex that no one can understand, totally ambiguous making

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

Professional from academic institutions, pharmaceutical industries, health care indust

a perfect breeding ground for lawyers to modify interpretation in order cheat the sys

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

tem, all for a fee. Throw in the financial gain of the free market place and now you h

.

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

ave a free for all and what on Earth did you expect in a system filled with humans and

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

Companies that provide selfless information through particip

system that does not take into consideration its own flaws? 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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Main Subject - Business Men, Lawmakers or Prosecutors; Who is the Most Honest?

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