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Bankruptcy law chapter 7, also often called straight bankruptcy is basically a liquidation process. You as a debtor must hand over all y

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

our property (except the exempt one) to the trustee who is appointed by the court. Trustee then sells of or changes that property in cas

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

Examples of combination products may in

that is returned back to your creditors.

You as a debtor are going to be discharged within a period of up to four months.

Why is bank

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

ruptcy law chapter 7 so popular?

If you have no property to lose, chapter 7 bankruptcy will provide you with an opportunity for a fresh

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

start. Or so it was before the 2005 bankruptcy law changes.

Bankruptcy law chapter 7 is without a doubt the most usual type of bankrupt

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

Combination pro

y filed in the US. It is usually filed for by either an individual or a business (business file usually for Chapter 11) when his debts b

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

ecome unbearable. You may choose to file for it by yourself or that decision may be forced upon you by the court.

If you are a business

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

you will be required to sell all of your assets, return money gained by the sell of to the creditors and close down your operation. For

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

individuals filing under bankruptcy law chapter 7 the process is similar with only difference being that you have nothing to close down

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

Be aware that under the new bankruptcy law some kind of debts can no longer be discharged.

So what are the advantages of filing under

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

bankruptcy law chapter 7?

1. Any debt amount can be completely cleared, and once you are discharged, you are 100% clear of debts.

2. T

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

Following aspects would a

here is also no minimum amount of debt needed in order to file for it.

3. Creditors no longer have any claim on you. Your wages and pos

dd to the challenges in developing combination products:

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

essions bought after the discharge are your own and nobody, except you, has any claim over them.

4. It is very fast, you stand a very g

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

ood chance of your claim being discharged in the next 4 - 6 months.

And the disadvantages are?

1. You can loose all your property.

2.

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

Not all debts can be discharged.

3. Your home loan co-signers can end up paying for your loans (unless they seek similar protection)

4

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

You can only file under bankruptcy law chapter 7 once every 6 years.

5. Your credit rating will be shattered (but there are ways to im

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

Professional from academic institutions, pharmaceutical industries, health care indust

prove it). In addition, you will find it much harder to get a loan of any kind.

6. If you are a young person, it will be very difficult

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

for you to buy home and start a family with chapter 7 around your neck, and if you are already married, you should know that divorce ver

.

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

y often accompanies bankruptcy.

7. Withdrawing your claim for Chapter 7 is extremely difficult if not impossible.

So there you have it

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

Companies that provide selfless information through particip

make sure to get a good bankruptcy lawyer and consult with her/him whether you should or should not file under bankruptcy law chapter 7

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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