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I just got done reading a series of articles dating from December 2000 to September 2001 (p

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

re-9-11) regarding Larry Ellison's bush to get the government to link all it's databases. N

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

Examples of combination products may in

w everyone agrees, but now we are post 9-11. I wonder if Larry Ellison as loud as he can be

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

sometimes ever stood up and said I told ya so? He would have every right to. He warned us.

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

ates did too, maybe not as verbal about it or graphic as Larry Ellison described the govern

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

Combination pro

ent’s computer databases like a file cabinet where one drawer was here and another across t

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 ocean in china in a dim lighted room.

Everyone kind of laughed and it was funny, he is g

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

od at poking fun. His hard line attitude may not have gotten the message across then, and w

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

did not listen because he did not have the political clout or proper snobbish decorative l

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

nguage of the polished and so eloquent politician slinging the Bull, but he was right. Gate

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

s was right too and said that government needs to reduce paper, yah no kidding. Well if the

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

Following aspects would a

will not say it, I will. They told you so. But you did not listen and therefore we got emb

dd to the challenges in developing combination products:

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

rrassed by a group of criminals who barrowed an airplane and had no intention of finding a

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

lace to park.

So now we spend 250 Billion in upgraded IT work after the fact and try to fo

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

ce databases and outdated hardware together for a seamless something that is suppose to pro

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

ect us? But darn we are stupid. Should we continue to make the same mistakes, or should we

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

Professional from academic institutions, pharmaceutical industries, health care indust

ollow the lead of the entrepreneurs who now have accumulated one hell of a lot of know how.

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

Next time a major Entrepreneur or Capitalist makes a statement about a trend they see out t

.

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

ere, we ought to listen, because 9-11 could have easily have been prevented if we had our t

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

Companies that provide selfless information through particip

ams of agencies working together with cohesive databases. Let’s pay attention in the future

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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