Advice You - Business

Although the homeless situation in the United States of America is un

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

der the radar and is only about 500,000 people, which is statisticall

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

Examples of combination products may in

lower than any other nation in the world, it still drives people cra

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

zy. Additionally we do need to do something about the homeless folks

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

in our nation, but unfortunately homeless shelters are something that

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

Combination pro

no one wants in the community.

The NIMBY affect is alive and well wh

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

en it comes to people who wish to put in a homeless shelter. No one

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

ants homeless people all around their businesses or in their neighbor

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

oods, as it attracts the wrong element and potentially can lead to th

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

eft in the area. Homeless shelters need to be very aware of the impor

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

ance of public relations and community goodwill in their local areas.

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

Following aspects would a

Convincing local residents, that a homeless shelter will be going in

dd to the challenges in developing combination products:

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

down the street usually sends a firestorm of frenzy to the local pla

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

ning commission meeting. However, if the homeless shelters promoters

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

can do a bang up PR job in advance using all the local media and gett

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

ing local politicians and community leaders to sign on to the project

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

Professional from academic institutions, pharmaceutical industries, health care indust

then much of the outrage can be eliminated before it starts.

We mus

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

do something about the homeless situation in the United States of Am

.

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

erica and homeless shelters are the answer to help those that want to

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

Companies that provide selfless information through particip

get off the street with an easier path. Please consider 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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