Main Subject - Business

Is it possible to beat the game even win the game is flawed? Often, as we grow in experience an

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

d observation we find that we are competing in a world, which lacks the integrity that we might

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

Examples of combination products may in

ave assumed it had. Often when we are working in an industry and we are working against competi

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

tion we find that the competition is cheating and the game is flawed and even the regulatory bod

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

es and all the legal eagles are all in cahoots with each other.

When this happens one needs to

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

Combination pro

e-look at the goals that they have set for themselves and understand the larger picture and thei

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

r place in the overall game. Sometimes when this happens it makes sense to join the group that

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

re the rule makers.

For instance it makes sense to be pragmatic and to perhaps join the industr

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

y associations and even sit on committees that make the rules and this way you can find out what

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

the real rules are and what they are not. It is possible to win in a game that is flawed and it

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

s possible to beat the game by changing the rules at the rule changing level or finding some ope

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

Following aspects would a

n space to run that are not included in the over regulation that has been put there by the compe

dd to the challenges in developing combination products:

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

ition.

This is not to say that you should break the rules, but rather realize who put the rules

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

there and why. Often the rules are not to protect the consumer or the integrity of the industr

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

but rather they have been put there by your competition to put up barriers to entry for busines

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

es like yours.

Once you understand these truths and you are done throwing up and barfing over t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he complete BS, then you need to ask yourself do you still want to play in the game and are you

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

illing to change the game.

Another option is to step out of the game to observe it and start yo

.

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

ur own you game to win that? This is something that every businessperson needs to ask themsleve

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

Companies that provide selfless information through particip

somewhere along the way if indeed they want to be number one. Please 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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Many employees do not wish to work hard; some are disillusioned and others feel the pay and benefits are substandard. Indeed although the unemployment is below 5% some feel that they are under employed.

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