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Every year, more than a million people file for personal bankruptcy to save them selves from drowning in debt. However, filing for bankruptcy is n

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

ot a simple task. To file for bankruptcy, a debtor must first file a petition with a federal bankruptcy court. The court appoints a trustee, who

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

Examples of combination products may in

oversees your case with your creditors and allows an "automatic stay" order, which holds them back from seizing your bank accounts, repossessing y

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

ur vehicle or house.

Types of Bankruptcy

There are two types of bankruptcy that one can file for:

1) Chapter Seven or "straight" bankru

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

tcy.

2) Chapter Thirteen, or "wage-earner" bankruptcy.

Each one operates in a different way:

Chapter 7: Liquidation

An individual or bu

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

Combination pro

iness can request the court to eliminate their debts. After filling details of your property, income, and basic monthly expenses, you attend a hea

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

ring with your trustee. This meeting will decide which non-exempt property should be sold to arrange for the proceeds which will go towards paying

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

off creditors. Depending upon the State you belong to, some property will be partially exempted (equity of your home, life insurance, retirement p

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

an assets and most furniture and household goods).

Chapter 7 bankruptcy takes six months and costs $175 which can be waived for people on public

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

ssistance or below poverty level. If already applied for in the last six years, or if someone co-signed a loan for you, or if you landed a luxury

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

ebt after filing, you’re not eligible to apply again. If the court feels that you are capable of repaying your debt in the next five years, they c

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

Following aspects would a

ould recommend your case for Chapter 13 instead.

Chapter 13

A steady high enough income to cover monthly expenses and due, is a prerequi

dd to the challenges in developing combination products:

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

ite to qualify and then a repayment plan will be fixed to payoff debts over the next five years. The filing fee is $160. Payments are made to your

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

trustee, who pays your creditors. Secured debts (home and car loans) must be under $750,000. If your unsecured debts (credit cards, department sto

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

e cards, medical bills, student loans) are under $250,000 you can keep your property under certain circumstances.

The Right Decision

Ba

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

kruptcy can have a damaging effect in the long run. The effects can remain on your credit report for as long as 10 years, even if you don't go thr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ough with the process. You will see the effects when applying for a high salaried job, or insurance above a certain figure. A bankruptcy on your c

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

edit report tells everyone you’re incapable of good financial management.

As an alternative to bankruptcy you can negotiate with creditors or see

.

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

help from debt-management counselors. Many non-profit organizations offer guidance and informat

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

Companies that provide selfless information through particip

on for free. Always seek help before filing for bankruptcy. And always make yourself this question: Will filing for bankruptcy solve your problems

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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Goal setting is more than just wishing something will happen. It is a process that provides the road map for any business.

The beauty of e-commerce is that you don’t have to pound the pavement in search of buyers—they are already pounding the cyber sidewalk looking for sellers. However, you must still help your market find you amongst the billions of web pages competing for its attention. Strategically selected keywords can be your best friends in attracting niche traffic that is willing to spend.

Resale Rights. Some people have a pretty good clue of what that means. Others are totally in the dark. But very few realize that resale rights are kind of like Heinz Ketchup. There may not be 57 different varieties, but there are enough to make the average marketer scratch his head and wonder where to begin when it comes to either creating his own product with resale rights or getting involved with an already existing product.

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