Advice You - Finance

During the 2005 Atlantic tropical hurricane season there were many

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

bankruptcies from small businesses and individuals who could not pa

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

Examples of combination products may in

their bills. All along the Gulf Coast, New Orleans and many peopl

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

in Florida had lost everything including their jobs, their homes a

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 had no way to support themselves or pay the bills.

Luckily FEMA

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

Combination pro

as able to come forth with monies, but generally it was not enough

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

or them and the checks came too late. Anyone who is ever done busi

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

ess with the government of the United States of America knows that

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

hey never pay their bills on time for services rendered and it shou

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

d not be surprising that FEMA did not cut checks to the people in t

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

eir time of need in the aftermath of hurricane Katrina.

It is esse

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

Following aspects would a

tial that individuals and small businesses keep their debt to a min

dd to the challenges in developing combination products:

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

mum if they live in a hostile hurricane territory or regions known

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

or hurricane strikes along the shoreline. Even though the bankrupt

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

y laws have changed in the United States over the last year, a pers

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

n can still get relief if it is absolutely necessary without destro

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing too much of their credit.

The small business administration al

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

o has loans available to help with debt consolidation and perhaps t

.

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

at is a way to prevent bankruptcy of your small business or loss of

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

Companies that provide selfless information through particip

your personal assets. All these things you should consider 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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