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The legal provision of bankruptcy, though sometimes misused, is a progressive and often merc

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

iful process. By it, a hopelessly indebted individual can make an official declaration of fi

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

Examples of combination products may in

ancial inability and be free of obligation. This may be on a temporary or permanent basis, d

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

epending on the degree of insolvency.

With new amendments in US laws, there is little or no

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

social or corporate stigma attached to filing for bankruptcy. Filing for bankruptcy, though

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

Combination pro

a matter of public record, no longer means that it becomes a matter of public knowledge. Eff

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

ctively, this is an incentive for the bankrupt party to make another attempt at financial so

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

lvency. An individual can file for bankruptcy under Chapter 7(for irreversible insolvency) o

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

Chapter 13(for temporary insolvency).

The benefits of filing for bankruptcy include restor

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 of bank credit via a secured credit card. This requires a certain deposit to be made,

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

ut a new line of credit can be established within two years of doing so. Meanwhile, the bank

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

Following aspects would a

upt person has assured freedom from harassment by previous creditors.

The US Congress amend

dd to the challenges in developing combination products:

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

ed the US bankruptcy code(ratified in 1978) in 2005, and further amendments were made on Oct

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

ber 17, 2005, to discourage the abuse of the generous provisions available. In fact, the pas

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

sing of these amendments was preceded by a literal stampede on bankruptcy courts by people h

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

ping to beat their enactment.

Under the revised Bankruptcy Abuse Prevention and Consumer Pr

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

Professional from academic institutions, pharmaceutical industries, health care indust

otection Act of 2005, (BAPCPA), someone filing for bankruptcy is subjected to stringent test

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

to establish genuine insolvency and present income. Another provision is that people dwelli

.

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

ng in any particular state, must be residents of that state for at least two years to be eli

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

Companies that provide selfless information through particip

ible. Bankruptcy laws do not provide a shelter against alimony and child support obligations

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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Sitting in a 70 year-old restaurant yesterday, an antique by California standards, I heard song after song from the Big Band Era, the 1940’s. My parents were fond of this music, Mom especially, because she sang in one of those roving orchestras long before I was a mere bubble in a champagne glass. The waitress, who might have been born in the place, asked me if I wanted some rye bread with my meal, and it got me to thinking about an expression from that bygone era: “Know how your bread is buttered!” For salespeople, this is a keen point. We need to know what it is that we’re doing that really makes sales happen, do more of that, and cut out anything that doesn’t contribute; needless motions and activity. Especially important is dispensing with ILLUSIONS about what is working for us and what is not working, according to Dr. Gary S. Goodman, top speaker and sales trainer, best-selling author, and Fortune 1000 consultant.

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