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Bankruptcy can be defined in several ways. In simple terms bankruptcy is a legally declared inability or impairment of ability of a person or organizat

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

ion to pay their creditors. A declared state of bankruptcy can be requested or initiated by the bankrupt person or company, or it can just be requested

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

Examples of combination products may in

by creditors in an effort to recoup a portion of what the company or individual owes them. However in the most of the cases the bankrupt individual or

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

the organization initiates bankruptcy.

Bankruptcy has become quite common these days. There are several reasons behind it out of which the foremost an

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

important factor is credit card payments and bank loans. Nowadays people are extremely burdened by the credit card bills and other loans that they tak

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

Combination pro

e at the time of need. After a certain time these bills and the loan repayment amount start increasing day-by-day due to the interest charged over them

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

This makes it all the more problematic for the concerned person to finish off with his debts. Therefore an individual should avoid taking loans and

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

making credit card payments as much as possible.

In order to prevent the growing bankruptcy cases government has proposed a new law. This new federal

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

aw has made it clearly mandatory for any person opting for a loan to join a counseling session before six months of filing for bankruptcy. The law also

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

states that people complete a financial education course before their bankruptcies are final, and credit counselors will have some of these courses.

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

his law has proved to be a great help to the people who confront the trauma of bankruptcy. But on the same hand it is a very expensive idea. People hav

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

Following aspects would a

to pay $50 for 90-minute counseling session.

Prevention is better than cure. So in order to avoid counseling and burden of loans etc. it is better th

dd to the challenges in developing combination products:

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

at you plan your payments. This has become all the more important after the minimum payment for credit cards has increased.

However while seeking bank

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

uptcy advice you should ensure that the advice is specific to your situation. Deciding where to go and what to do is another big issue like bankruptcy

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

itself. But the fact is that a large number of individuals and businesses do not need to enter into a formal bankruptcy.

The usual time for a bankrupt

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

to automatically be discharged is two years if it is the first time that you have gone bankrupt and unsecured creditors are less than ? 20,000 and thre

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

Professional from academic institutions, pharmaceutical industries, health care indust

e years if unsecured creditors are in excess of ? 20,000.

The main objective of bankruptcy is to convert your belongings or assets, and any salary you

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

receive into lump sum and installment payments for creditors. The purpose of a debtor applying for his own bankruptcy is to form a moratorium (group of

.

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

creditors) to have consent on partial repayment of all outstanding debts, and when the agreed repayment has been met, to have a ‘clean slate’.

If you

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

Companies that provide selfless information through particip

have your own house then you would be lucky enough to keep it. All essential household commodities but not TV’s, video recorders, computers can be kept

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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