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Many reports and news articles are reporting that there are som

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

e 10-12 million illegal aliens in the country. Bulloney! They w

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

Examples of combination products may in

re saying that over 7-years ago. Additionally there are some 4

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

illion over stayed VISAs too. So even by those figures we have

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

4-16 million illegal aliens in our nation.

Indeed there are mi

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

Combination pro

lions of Illegal Aliens in our country and I noted recently whe

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

reviewing old material that on my first Blog in 1998, yes I se

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

em to be a trendsetter? I wrote an article that there were 10-1

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

million estimated Illegal Aliens in this country and it would

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

eem to me that now at 1 million per year that there would be 19

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

21 million illegal aliens, plus the 4 million known over stayed

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

Following aspects would a

Visa passes. Meaning 24-25 million. Plus right now they estimat

dd to the challenges in developing combination products:

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

500,000 illegal aliens per quarter. 60% coming from Central Am

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

rica and Mexico, well at least coming over the Mexican Border y

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

ou see?

We must not lie to ourselves as to the real number of

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

llegal aliens in our nation and the Census Report does not tell

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

Professional from academic institutions, pharmaceutical industries, health care indust

us either. There is no real empirical to substantiate the true

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

umber of illegal aliens in the United States of America and to

.

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

retend that the number is 10-12 million is simply white washing

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

Companies that provide selfless information through particip

the seriousness of this issue. So, please consider 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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So many people are looking for the big possibilities, the big markets, but can you sometimes get too big? People are finding more and more ways to creep in with different niches and niche marketing and they are really making a killing on these niches.

If you have ever had a great concept for an article and then forgotten it later then there is an easy way to recall this information from your memory without stressing out over it and chastising yourself. You see when you forget your article's direction, put yourself back in time and place to where you...

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