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The world remains horrified at the tremendous destruction caused throughout the Gulf Coast recently by Hurricane Katri

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

na. An unknown number of people are dead and thousands more are homeless, jobless and completely destitute. It may b

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

Examples of combination products may in

months before the city of New Orleans is inhabitable again, and in the meantime, most residents of the city will have

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

little or no income. This is a problem, as most people will continue to have payments due for credit cards, auto loan

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

and mortgages. A number of people will probably be forced to file for bankruptcy as their debts continue to pile up

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

Combination pro

ith no income to offset them. Unfortunately for them, recently passed legislation may make it difficult, if not impos

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

sible, for them to have their debts wiped away through bankruptcy.

The Bankruptcy Abuse and Consumer Protection Act,

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

igned into law by President Bush last April, makes it more difficult to file for bankruptcy than in the past. New, st

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

icter guidelines, which take effect next month, require proof of income for six months prior to filing as well as cred

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

t counseling. The documentation requirements of the new law are fairly strict, and even hold attorneys who represent

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

ankruptcy filers liable for incorrect information filed on their clients’ behalf.

These will be huge obstacles for hu

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

Following aspects would a

rricane victims, many of whom have lost their homes and contents. Along with their furniture, clothes and other posse

dd to the challenges in developing combination products:

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

sions, victims of the storm have also lost vital paperwork outlining their debt obligations and income. Without this

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

aperwork, it will be virtually impossible to file under Chapter 7 of the Federal code, which allows the courts to wipe

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

out most consumer debts. Instead, filers will have to file under Chapter 13 and establish a repayment plan. This wil

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

undoubtedly create an undue burden on thousands of largely uninsured hurricane victims as they try to pay the bills f

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

Professional from academic institutions, pharmaceutical industries, health care indust

or personal belongings that no longer exist.

Congress has taken note of this situation and a number of Democrats are

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

ttempting to pass new legislation that will assist victims of Hurricane Katrina with bankruptcy filings. It appears a

.

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

present that no Republicans are willing to support this legislation, so anyone who has suffered a loss from the storm

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

Companies that provide selfless information through particip

should try to gather financial information together as best they can and prepare for a long and expensive day in court

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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The object of every marketing communication is to prompt action. The action can be to remember a name, a price or a point of view. No action, you're dead.

As small businesses we have an opportunity and an obligation to help keep our communities strong. As small business people we have an awesome distribution system, reaching hundreds of people every day who come into our stores. If we are a mobile service business we see hundreds per day on our route. If you volunteer to deliver flyers to all your customers for an upcoming club event, you can develop incredible rapport with these groups. Community Based Marketing Strategies.

One of the key challenges for any business is to remain focused and invest resources for maximum pay-off. It's said that 80% of a business's activity accounts for only 20% of total profits. In plain language, most of the work we do is unfocused, poorly designed and ineffective. In today's competitive world, no business, whether it's an individual professional or a large manufacturing operation, can survive with that much lost time and wasted effort. A business plan can help, but most small business owners (and some managers/supervisors) hate doing them! In the spirit that any map is better than no map, here are my top ten keys to creating your own map to success:

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