Write You - Home Based Business

If you have a home business in a devastated or destroyed area or

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

region of the United States of America which was hit by a large

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

Examples of combination products may in

category storm during the 2005 or 2006 Atlantic tropical hurrica

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

ne season, then you'll have to work very hard to rebuild your bu

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

iness and make sure you maintain your cash flow during this rebu

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

Combination pro

lding period.

Hurricanes can be most damaging to home businesse

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

s because often phone lines will be out and the power will be ou

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

and it is almost impossible to run your business when all this

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

s occurring. Also as you try to leave the area with your family

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

during mandatory evacuations you cannot always take all your co

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

puters, printers and peripherals as well as the inventory you ne

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

Following aspects would a

d to run your business.

FEMA and other government agencies incl

dd to the challenges in developing combination products:

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

uding the SBA Small Business Administration understand these thi

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

gs and they have loans available for all businesses due to this

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

act. The only problem is it takes a long time to get your check

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

and the bills including your credit cards cannot always stop an

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

Professional from academic institutions, pharmaceutical industries, health care indust

wait for you to catch up.

If you own a home small business tha

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

you need to have a hurricane disaster plan or have thought out

.

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

in advance how you will be able to run your business if a major

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

Companies that provide selfless information through particip

urricane comes your way. I hope you will consider all this 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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