Main Subject - Business

In the last several years we have seen an increase in off shoring and

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

outsourcing and many television commentators have made mention of th

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

Examples of combination products may in

s. In fact Lou Dobbs has gone out of his way to condemn some of Ameri

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

ca’s largest corporations, yet when you stop and consider why this is

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

happening, it is not the Corporations we should be blaming but rather

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

Combination pro

ourselves. Why is that you ask? Well simple really as it is the peopl

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 who own the government and the government has over regulated our bu

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

iness community at all levels.

With all the costs to comply with all

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

this regulation our government, which is owned by us has given an ad

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

antage to our overseas competitors who do not comply with our laws he

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

e? Interesting that we hold our own companies to such a higher standa

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

Following aspects would a

rd and then completely tilt the playing field for the foreign competi

dd to the challenges in developing combination products:

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

ors. But our companies got smart and said;

“Well fine then, we too w

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

ill become foreign companies, avoid heavy taxation, regulations and t

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

e class action lawyers who manipulate the law to steal from us.”

If

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

ou were these large corporations what would you do if you were totall

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

Professional from academic institutions, pharmaceutical industries, health care indust

y harassed? Additionally the labor is cheaper in these other nations

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

oo, so the more you outsource the more you win all the way around the

.

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

game. Blame the government and the people that own the government, Y

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

Companies that provide selfless information through particip

U for the outsourcing of Corporate America. Consider all 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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