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Chapters 13 has been introduced as a type of bankruptcy filing for individuals with a fair income, keeping in

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

mind their intent to pay their debts but are unable to do so in a timely manner. The underlying principle of C

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

Examples of combination products may in

hapter 13 is to facilitate financially distressed individual debtors to propose and carry out a settlement pla

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

n under which creditors are paid over an extended period of time. Upon filing for Chapter 13 discharge a perso

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

n can expect the following advantages and disadvantages.

On filing for a Chapter 13 discharge, barring a few

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

Combination pro

rominent exceptions, all other ongoing legal actions against the debtor are stopped. A creditor is prohibited

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

from carrying out new legal actions against the debtor. It also stops creditors from corresponding with the de

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

btor, or any person except the debtor's lawyer, to discuss or ask for collection of a debt. Often, it is obser

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

ved that liabilities relating to credit card debts, civil judgments, past-due accounts, and rulings due to rep

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

ossessions and foreclosures may be settled in this manner. Similarly, by filing for Chapter 13 people can also

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

expect to keep all or majority of their property through federal or state exemptions. However, a person can on

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

Following aspects would a

ly expect to evade certain liens and specific involuntary transfers such as garnishments if timely action has

dd to the challenges in developing combination products:

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

been taken.

Filing of Chapter 13 has a number of cons. A person should only rely on the same as a last resort

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

. A person filing for Chapter 13 bankruptcy should be prepared to face a number of undesirable consequences. A

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

mount relating to certain taxes, governmental fines, forfeitures and reimbursement, child and spousal support,

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

or drunk driving may not be dischargeable. Creditors who have security interest in a home or in motor vehicles

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

Professional from academic institutions, pharmaceutical industries, health care indust

may be able to retrieve their collateral after the bankruptcy unless the debtor reaffirms the debt. Bankrupt

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

candidates should not expect to obtain easy credit in the future. Disrepute may be associated with bankruptcy,

.

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

which views a debtor as being financially or socially negligent. As such, a person should be mentally prepare

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

Companies that provide selfless information through particip

d to accept the same. Along with this, a person can also expect significant tax consequences from a bankruptcy

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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