Main Subject - Finance

The Bankruptcy Abuse and Consumer Protection Act, signed into law last April, will take effect this month an

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

d bring with it some of the most sweeping changes in debt law in history. As the new requirements are much

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

Examples of combination products may in

ore strict, expensive, and time consuming than the old ones, consumers with problem debt are rushing to file

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

now. But many others are wondering if their debt problems are serious enough to warrant the rather drastic

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

decision to file for bankruptcy.

Here are a few things that may help you reach a decision:

You have tw

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

Combination pro

o or more major credit cards with outstanding balances – Credit cards work best when used for convenience, s

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

ch as when you don’t have cash with you or when it just isn’t convenient to pay cash. They work less well w

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

hen you use them as a funding source, as they represent a fairly expensive way to borrow money. If you have

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

more than two major credit cards with outstanding balances that are high enough that you cannot pay any one

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

of them off right now, you may have a problem.

You make minimum payments only on your credit cards

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

– The minimum payment doesn’t even put a dent in your balance, and until recently, the minimum wouldn’t even

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

Following aspects would a

cover the interest accrued during the month. If you are only making minimum payments on your credit cards

dd to the challenges in developing combination products:

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

ecause you cannot afford to send more, then you may be in over your head.

You are paying one credi

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

t card bill with another credit card – Taking a cash advance on a credit card is really expensive. The int

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

rest rate is usually higher than for purchases and the cash advance often includes an additional fee. If yo

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

u are taking a cash advance from one card at 20% interest to make a payment on another at 20% interest, you

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

Professional from academic institutions, pharmaceutical industries, health care indust

re probably in trouble.

This list is by no means definitive or complete. Nor should it be construed a

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

s legal advice. But if you see yourself doing one or more of the things listed above regularly, it may sugg

.

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

st that your financial problems are quite serious. Now would be a good time to consult with either a financ

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

Companies that provide selfless information through particip

ial advisor or a bankruptcy attorney. Financial problems only get worse when left unattended, so don’t wait

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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A relatively little used option, for inventors and entrepreneurs, with limited ability to fund or license their product, is the Strategic Alliance. A Strategic Alliance enables a product, invention or service to become absorbed within the structure of a going business. The business handles all aspects of production, sales, marketing and finance as if the item was invented in house. In return, the inventor receives an income stream for a defined share of the profits generated by the product, a consulting agreement or employment working in his area of expertise on the project.

The most sure fire way to produce quality work is to follow the process of prolific production:

Simplified employee pension (SEP) plans make it possible for small businesses to provide retirement benefits with lower costs and less reporting requirements than other qualified retirement plans. In fact, SEPs offer some attractive benefits for employers and employees alike.

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