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Things are bad, really bad. They have to be for you to be considering bankruptcy. It’s true that bankruptcy can wipe away your debts, or most of them anyway. Taxes are exempt from bankruptcy protection. You can declare b

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

ankruptcy, but if a substantial portion of your outstanding debt is back taxes, interest and penalties, you are not going to escape. If, however, most of your debt is credit card debt, mortgage, car loans and other consu

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

Examples of combination products may in

er or business debt, there is a chance you may successfully escape most or all of your financial obligations.

Even so, is bankruptcy the best alternative for you? If you do declare bankruptcy, which type of bankruptcy s

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

ould you consider? How will the new federal bankruptcy reform statute that goes into effect on October 17, 2005 affect you? In most cases you should be seeking qualified legal counsel for the answers to these questions.

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

The devil, as they say, is in the details. You don’t want to make a small mistake when declaring bankruptcy, only to lose some of the protection to which you are entitled. You only want to do this once. It will for follo

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

Combination pro

you around for 10 years in the case of a Chapter 7 bankruptcy. Make sure your attorney is a bankruptcy specialist. Just using your uncle Joe who happens to be a lawyer may be a big mistake.

There are two types of bankr

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

ptcy for private individuals, chapter 7 and chapter 13. With Chapter 7 you can generally escape from all debt with a few exceptions such as state and federal taxes. You can keep certain exempt property as well. There is

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

federal exemption list Most states have an exemption list too. Most states require you use the state list but some allow you to choose from either the state or federal list. Property not on the list is sold to satisfy p

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

y creditors.

Chapter 13 bankruptcy will require renegotiation and repayment of your debts. You will first file a petition for bankruptcy with the court and a trustee will be appointed. If your income exceeds your expens

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

s, you will usually be required by the court to use the Chapter 13 option.

You will want to examine which alternative is the correct one for you. In fact, there are other alternatives to serious debt problems besides ba

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

kruptcy. One of these is a debt consolidation loan. Debt consolidation loans are growing in popularity due to many factors including the rise in homeowner’s equity, record low interest rates, and a dramatic increase in t

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

Following aspects would a

he level of consumer debt. This option can be much more attractive than bankruptcy. If you can keep from declaring bankruptcy, you will not have the social stigma and long term credit issues to deal with. There are liter

dd to the challenges in developing combination products:

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

lly hundreds of debt consolidation options available from many different lenders.

A debt consolidation loan is basically just a home equity loan used to pay off your higher interest debts. Because the loan is secured by

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

real estate or some other valuable collateral, you get a substantially lower interest rate than can be had for most unsecured debts, such as credit cards. This contributes to a lower payment. In addition the term of the

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

oan is usually longer than a credit card, contributing further to lowering the monthly payment. The decrease in monthly outflow can be just what the doctor ordered and can prevent bankruptcy. Be advised however, if the c

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

nditions that caused your monthly payments to rise are not corrected, you risk ending up facing bad credit problems again.

There are downsides to debt consolidation loans as well. First, you could lose your home. Also,

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou use up the equity in your home so you won’t have to bail you out a second time.

Another alternative to bankruptcy is credit counseling. With this option, a credit counseling firm works with you and your creditors to

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

rrange lower payments, make your debts current (called re-aging), and even possibly forgo a portion of your debt. This is an attractive option for many. It is being mandated by the new federal bankruptcy legislation as 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

step before bankruptcy in many occasions.

You may have to declare bankruptcy. It may even be the best course of action for you. However, bankruptcy may not be the best way to go and there are other alternatives. Do care

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

Companies that provide selfless information through particip

ul research on bankruptcy and the alternatives and evaluate your personal situation carefully before you make your decision

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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