Main Subject - Finance

Filing for bankruptcy can be an excruciating moment. Individuals or firms have the option of filing for bankr

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

uptcy as a last option when their debts are out of control. Bankruptcy is filed when the debt is extremely hi

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

Examples of combination products may in

h and the creditors are practically camping at the door. Expenses due to medical, legal, or credit card expen

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

es usually make a person lean towards the option of bankruptcy.

Even though bankruptcy provides the individu

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

l with a credit free life later, it affects the credit rating for about 10 years, so filing for bankruptcy is

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

Combination pro

not really a very easy option. Also, some cases, such as those dealing with mortgage and alimony, may not ev

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

n be considered in the court as proper reasons for bankruptcy. Bankruptcy must also be considered only when a

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

l other options have been exhausted.

It is possible for the individual to represent himself in court when fi

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

ing for bankruptcy. However, most bankruptcy laws can seem to be very complicated to a common citizen, so it

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

is suggested to pay a visit to an attorney before filing for bankruptcy. Most attorneys will be able to give

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

lients the general gist of the procedure and an attorney dealing with credit counseling will be able to provi

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

Following aspects would a

e proper guidance.

Most attorneys provide a free consultation regarding the case. It is very important to ch

dd to the challenges in developing combination products:

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

ose a proper attorney as they can make or break the case by not being actively involved.

It is suggested to

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

run a few enquiries rather than hiring an attorney solely based on the attractive advertisements. Many law fi

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

ms have licensed attorneys specialized in dealing with bankruptcy cases. It is suggested to select one of 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

e attorneys to deal with the case.

ACcording to a new bankruptcy law that was passed in 2005, credit counsel

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng from a licensed firm is a must at least six months before filing for bankruptcy. Keeping this into account

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

, lots of law firms have started offering these services to the public. These companies are licensed and have

.

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

representative agents who can help individuals and firms with the credit problems. They might even be able to

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

Companies that provide selfless information through particip

provide a solution so that the firm or the individual can reach to some form of settlement with the creditors

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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