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Bankruptcy is defined as a legally declared inability or incapability of an individual or organization to pay thei

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

r creditors. Personal bankruptcy is an option limited to individuals who are bankrupt and does not include organiz

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

Examples of combination products may in

tions or companies.

The main objective behind filing a bankruptcy is to absolve financial debts and make a fresh

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

start. Individuals can file for personal bankruptcy under chapter 7 of the bankruptcy act after they take a credit

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

counseling course, completed an approved financial management course before discharge and after passing the ?means

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

Combination pro

test?.

Debtors filing Chapter 7 or Chapter 13 bankruptcy must present a copy of a tax return or transcription of

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

a tax return of the period for which the return was most recently due to the trustee, at least seven days before t

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

he 341 meeting

The documentation required for filing for personal bankruptcy includes a list of creditors, detail

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

d description of current income, current personal expenses, and an identification photograph. Under the new bankru

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

ptcy laws a person also has to submit a certificate of counseling and a proof of income for the last six months. P

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

oof of income includes copy of paycheck, a pay stub, bank statements, rental agreements, books and records, or any

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

Following aspects would a

other evidence of income a person has received within six months of filing. The last 60 days worth of paycheck st

dd to the challenges in developing combination products:

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

bs must also be filed along with the bankruptcy paperwork in the bankruptcy court.

A statement of monthly net inc

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

ome and any anticipated increase in income after the filing should also be mentioned. All the tax returns or trans

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

ripts for the previous four (4) tax years are to be submitted. Tax returns that were not filed during the 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

cy case will also be needed. Other documents include copies of deeds, mortgages and titles to vehicles, copy of th

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

Professional from academic institutions, pharmaceutical industries, health care indust

individual?s automobile financing agreement and any creditor?s mail that the person has received within the last

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

90 days before filing. Copy of security agreements with secured creditors and copies of divorce decrees, property

.

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

ettlement agreements, separation agreements and child support orders also have to be included along with an applic

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

Companies that provide selfless information through particip

ation for personal bankruptcy. It is always advisable to contact an attorney before filing for personal 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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