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When it comes to filing Chapter 7, the process is one that is complex and takes time. You can’t just walk into your

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

attorney’s office and expect to have the bankruptcy discharged. The fact is that your creditors can actually fight

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

Examples of combination products may in

you on this. You can have to meet various requirements. With the new laws that are in place, you may have to reall

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

work to earn this privilege. With all of that said, will you make it through filing Chapter 7?

Hire An Attorney

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

hile you can file bankruptcy on your own, it is much more efficient and economic to hire an attorney that specialize

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

Combination pro

in bankruptcy. He or she will work with you to find the best possible solution for your needs. They will also wor

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

k with you to meet with your creditors, to come to an agreement, and to file all of the legal work that must be file

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

in order for this to happen, without a problem.

Get Your Debts Together

The next thing that you’ll have to handle

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

is finding out who you owe money to as well as how much you owe them. You’ll need to gather account numbers for tho

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

e accounts and find out if anyone else’s name is on those debts as well. You’ll need to do this so that you can acc

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

rately clean up your debt. If something is not included in the filing of Chapter 7, you’ll still be responsible for

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

Following aspects would a

it afterwards. One way to check on what you owe is to pull your own credit report from each of the credit agencies

dd to the challenges in developing combination products:

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

This will give you a good idea of who you owe money to, although it may not list everyone.

More To Do

Still, the

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

e is much to consider. For example, you’ll need to determine that you are eligible to file Chapter 7. With the new

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

bankruptcy laws in place, this can be somewhat of a challenge. Not everyone is eligible and you may have to work th

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

ough credit counseling services before you actually can have your discharge happen.

Once you get through the paperw

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

Professional from academic institutions, pharmaceutical industries, health care indust

ork, you’ll sign on the dotted line. But, that doesn’t mean that all is done. In fact, it can take three to four m

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

re months for the proper courts to decide if in fact you are eligible to file as well as if you should be granted th

.

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

s opportunity. If so, you will receive official word of your filing within that amount of time. The entire process

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

Companies that provide selfless information through particip

can take a year or more to happen. Filing Chapter 7 is time consuming, but something that must be done nevertheless

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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