Advice You - Business

In the United States we have an abundance of raw materials and natural resources.

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

Many of the mines in the United States of America have been shut down and we get

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

Examples of combination products may in

much of our raw materials from other nations, which have to be shipped here at a

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

ery high cost. Many of the raw materials we get from other nations are not as go

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

d as the raw materials we have here and that is a real problem.

Likewise in the

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

Combination pro

uture many of the raw materials we have in the United States we will not need bec

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

ause the likelihood of us making things out of steel and copper are not too proba

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

le. We will have nano tubes may have carbon, fiber optics, special composites an

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

super alloys made from exotic metals or that have be re-engineered at the molecu

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

ar level. Because this is the obvious future, we should use our own raw material

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

in the United States first.

Many economists and the old way of thinking believe

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

Following aspects would a

we should use raw materials from other nations first and then when they ran out

dd to the challenges in developing combination products:

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

e would be last with our own raw materials and not have anything to worry about.

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

However technology and the rapid advances in research and development has shown u

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

that in the future we will not need these raw materials anyway.

Our goal theref

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

re should be to use our own raw materials in the United States first and work on

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

Professional from academic institutions, pharmaceutical industries, health care indust

innovation initiatives and research and development grants to look towards the fu

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

ure for better materials to make things out of. As long as we can use our own ra

.

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

materials in a responsible and environmentally friendly way it makes sense to us

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

Companies that provide selfless information through particip

our US raw materials in the ground here first. Please 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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