Advice You - Finance

Individuals can file for personal bankruptcy as a last ditch effort when their credit rea

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

ches the limit. This helps them clear out a few debts by selling their assets and startin

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

Examples of combination products may in

g a whole new life without creditors beating at their door. The gives them an opportunity

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

to start afresh without credit worries since creditors have no more right to press colle

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

ction charges.

Presently, individuals can file for bankruptcy under Chapter 7 or Chapter

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

Combination pro

13. Chapter 7 involves liquidating all the assets to pay off the creditors. Chapter 13 in

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

volves registering a plan to pay of the creditors from the monthly wages of the debtor wi

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

thin a specified amount of time. However, new laws passed by the President in 2005 might

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

make the options for filing the case under Chapter 7 a bit more narrow and might force mo

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

st individuals to file a bankruptcy case under Chapter 13 instead.

Chapter 13 requires t

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

e individuals to provide proof of income, as the whole law is based on the individual’s s

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

Following aspects would a

teady income. If the debtor fails to pay the monthly credit amount, the case might be dis

dd to the challenges in developing combination products:

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

missed from the court and will require the individual to file for bankruptcy all over aga

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

in.

When an individual files for bankruptcy, it does provide him with a fresh start, but

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

the credit bureaus keep records of the bankruptcy details and this might affect the debt

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

r's credit rating for the next 10 years. However, some banks currently offer a new kind o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f credit card that requires some initial security payment that will help build up the cre

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

dit rating so that things are almost normal by two to three years.

The new law also requ

.

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

ires the individual to take up credit counseling at least six months before filing for ba

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

Companies that provide selfless information through particip

nkruptcy, which means the individual has to go through a licensed lawyer to file the case

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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