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There is always a crisis in the World somewhere and just pick up any n

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

ewspaper and we can see that is fact. During the Russian and USA stand

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

Examples of combination products may in

off which we conveniently called the; Cold War there was a “Missile Ga

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

p” and so we had to spend money to build more missiles and of course t

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

is is good news for Defense Contractors, as there is a lot less costs

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

Combination pro

in building missiles than aircraft and since those missile may never b

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

e fired they would not need lots of pilots to fly them or fuel to put

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

nside them and use up.

This means more money can be paid for the miss

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

iles themselves. Good deal, everyone wins, our nation is protected and

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

all is well right? Sure one could argue it worked.

Now we have an al

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

ernative fuel gap and one, which we must close because we are addicted

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

Following aspects would a

to foreign Middle Eastern Oil. Then only way to keep prices at accept

dd to the challenges in developing combination products:

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

able rates for our civilizations economy is to threaten the Oil Cartel

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

; OPEC with alternative energy sources and assure them that we are spe

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

ding money, big money in Research and Development Costs to build alter

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

native fuel vehicles, trucks, aircraft and etc.

So, we need to promot

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

Professional from academic institutions, pharmaceutical industries, health care indust

e the Alternative Fuel Gap as a huge crisis and promote up and coming

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

cientists and researchers to find ways to close that Gap and in doing

.

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

so everyone wins. The Alternative Fuel Gap is serious, so consider thi

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

Companies that provide selfless information through particip

s in 2006, because $3.00 per gallon is completely unacceptable you see

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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