Digg It - Finance

Bankruptcy is a legally declared inability of an individual or organization to pay cred

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

itors. During the course of a bankruptcy, a debtor may ask a court to dismiss the case.

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

Examples of combination products may in

If the court finds that dismissal will not harm the creditors, ordinarily a court will

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

rant a petition to dismiss a Chapter 7 or a Chapter 13 bankruptcy.

There are several r

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

asons a debtor may prefer to file a Chapter 13 bankruptcy petition. The reasons include

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

Combination pro

the debtor wishes to resolve certain debts that may not be discharged in a Chapter 7 ba

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

kruptcy. The debtor may also wish to protect certain cosigners on personal loans from

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

eing pursued by creditors for repayment or feels obligated to repay certain debts. The

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

ebtor may believe that future creditors will look more favorably on Chapter 13 reorgani

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

ation than a Chapter 7 discharge. A debtor may be required to file a Chapter 13 bankrup

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

cy if he or she has received a Chapter 7 bankruptcy discharge within the prior six year

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

Following aspects would a

s, or obtained a Chapter 13 bankruptcy discharge within the prior six years and has not

dd to the challenges in developing combination products:

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

paid off at least 70% of the unsecured debts and was subject to the discharge of a prio

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

Chapter 7 or Chapter 13 bankruptcy filing within the prior 180 days, because the debto

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

violated a court order, or requested dismissal after a creditor sought relief from the

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

automatic stay.

After filing a Chapter 7 bankruptcy petition, some debtors discover th

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

Professional from academic institutions, pharmaceutical industries, health care indust

t they are better served by pursuing relief under Chapter 13. By filing an appropriate

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

otion with the bankruptcy court, the debtor has an absolute right to convert the petiti

.

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

n to a Chapter 13 filing, if the debtor has not previously converted a Chapter 7 bankru

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

Companies that provide selfless information through particip

tcy to a Chapter 13 bankruptcy, and the debtor's estate qualifies for Chapter 13 relief

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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