Main Subject - Business

Many believe that it is human nature to make up stories, embellish a

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

nd tell tall tales. Indeed it appears that these folks who say this

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

Examples of combination products may in

are right, it must be human nature, because it is getting harder and

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

harder to get a straight answer out of people? Maybe it is all this

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

political correctness that people have just given up on the truth, i

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

Combination pro

nstead a perceived or contrived truth will do just fine?

If you thi

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

k about this for a second; "It is human nature to propagate!" Sure e

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

specially in groups, government agencies (as they defraud and misrep

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

resent) and such. And Monkeys do this too (sometimes the same). Monk

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

ys in observation use deception to mislead to allow them selves a be

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

tter helping of a meal by crying wolf, when their pecking order does

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

Following aspects would a

not allow for what they desire in the amounts they desire.

It seem

dd to the challenges in developing combination products:

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

deception, camouflage, hunting tactics are innate in most all speci

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

es on Earth and I suspect as we learn of life elsewhere we will see

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

more of the same. It might be interesting if we all might move beyon

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

that someday. So, does that make lying okay? No, because we have ag

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

Professional from academic institutions, pharmaceutical industries, health care indust

reed to live by certain rules in society. It would be best for all c

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

oncerned to be a little more honest, have a tad bit more integrity a

.

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

d perhaps, just maybe turn down the BS a notch or two. Indeed that m

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

Companies that provide selfless information through particip

y friends would be the best for all concerned. 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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