Advice You - Business

Every once in a while I will turn on the Television only to find

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

Lou Dobbs staring back at me saying would you Look Who is Outsour

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

Examples of combination products may in

cing Now? As if corporations have any choice. Why do I say this y

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

ou ask?

Well simple really with all the hoops the American Corpo

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

ations have to go through in the United States with the Unions, t

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

Combination pro

he class-action lawsuits, the Sarbanes Oxley regs and the insane

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

over the top rules and regulations it is no wonder Corporations m

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

ove their operations, factories off shore and outsource the rest.

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

Wouldn’t you to get away from the barrage of in coming mortar ro

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

unds from folks who should have already been on your team in the

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

first place? Why all the attacks against our own team is beyond m

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

Following aspects would a

e. It does not surprise me one bit.

I guess what surprises me mo

dd to the challenges in developing combination products:

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

t is that Lou Dobbs makes these corporations look like villains w

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

ithout getting to the root of the real problems and that is that

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

we are causing all this outsourcing and we, our government is cau

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

sing the loss of American Jobs, along with those Unions who suppl

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

Professional from academic institutions, pharmaceutical industries, health care indust

the labor now, but why I ask you; why?

Either we all get on the

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

same page and work together as a team or we are all in this sink

.

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

ing ship together and the end result is every man, woman and chil

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

Companies that provide selfless information through particip

d for themselves. Is that what Americans really want? I think not

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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