Actual - Legal

Many complain about the fact that Chinese companies often steal American products and re-engineer them 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 send them around the world to be sold in mass. In fact you do not have to look very hard in the United

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

Examples of combination products may in

tates on retail shelves to see knock off products of such. Many are made as inexpensively as possible, of

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

en with cheaper and inferior parts and brought over by the shipload. You cannot blame retailers for buyin

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

g these products at a fifth of the wholesale price and wishing to resale them for just under the average

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

Combination pro

etail price to the consumer. But each item sold that way which has been stolen or copied means fewer prod

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

cts are made here and that is upsetting to those who work in the American manufacturing sector. If you lo

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

st your job, I am sure you would agree.

Recently a think tanker and Autoworkers stated that if you are a

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

innovator and think that a patent will help you against a Chinese company stealing your work, forget it.

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

He said very matter of factly;

“find a way to protect your innovation before it gets "Shanghia'd"... and

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

you see it on a shelf in Wal-Mart, marked with the obligatory but tiny 'Made in China'...”

I completely

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

Following aspects would a

occur and have some comments on that matter too:

http://worldthinktank.net/wttbbs/index.php?s=b2d4e30bc3

dd to the challenges in developing combination products:

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

74fcf8a37fdef298522fd&showtopic=136

What I find totally a miss is with the Patent Theft and in our natio

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

the costs associated with filing patents and time to get them approved. It is a complete sham on the Ame

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

rican Innovator and the sharp minds of the American people. Too bad really because this slow process at o

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

r PTO prevents entrepreneurs from making money on their ideas and innovations and parlaying that up into

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

Professional from academic institutions, pharmaceutical industries, health care indust

ntire entrepreneurial R and D Companies.

http://ezinearticles.com/?id=122767

Further the total disregar

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

d by other nations to honor these patents is preventing those who would normal wish to innovate from doin

.

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. If these issues continue unchecked we will see a dwindling of innovation in the United States and fu

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

Companies that provide selfless information through particip

ther losses of monetary trade deficit outflows and jobs leaving for foreign shores. Think on 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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