Advice You - Finance

As the debate rages on whether or not you need an attorney for bankruptcy, we gave you reasons why you don’t need an attorney so now to

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

be fair to the lawyers we are going to tell you why you need an attorney. The first thing we should say is getting an attorney is a ma

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

Examples of combination products may in

ter of personal preference, we are not here to tell you yes you need one or no you don’t need one. Any decisions that need to be made

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

in any and all decisions relating to bankruptcy should b made by you; we are here giving advice not telling you what you need to do

Th

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

first thing when you consider bankruptcy is determine which Chapter you should file. Do your research, but unfortunately the ways some

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

Combination pro

of these descriptions of Chapters are so confusing you still don’t know after reading them whether or not they work for you. That is w

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

ere an attorney comes in; they can take the convoluted way legalese is written and turn it into simply layman’s terms. If you have any

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

question regarding any of the definitions of Chapter 7, Chapter 11 or Chapter 13, you can ask right then and there.

You will want to k

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

ow exactly what the laws are and how they pertain to you. Once you file a Chapter 7 which is liquidation you will need to know exactly

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

what paper work you will need to bring to court, the same as if you filed for Chapter 13 which is reorganization of your debt. You will

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

most likely need billing information and credit information. An attorney will let you know exactly what type of documentation you need.

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

Following aspects would a

An attorney can advise you on a stay that comes with your bankruptcy, a brief definition of a stay is a legal procedure that prohibits

dd to the challenges in developing combination products:

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

certain creditors from calling you to collect the money they are due. Your attorney will explain to you that a stay does not apply to

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

ll creditors.

All of these subjects we covered, an attorney must explain them to you but if you choose not to have an attorney then a

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

court appointed trustee can explain everything to you as well. Remember hiring an attorney is a matter of preference and if you feel mo

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 comfortable having an attorney handle the back end of the bankruptcy rather than you doing it. Keep in mind that bankruptcy attorneys

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

Professional from academic institutions, pharmaceutical industries, health care indust

are not cheap and you will pay no less than $ 1000 no matter where you live. Just another thing to consider.

Let’s review reasons to

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

et an bankruptcy attorney
1-To explain to you without a doubt in your mind which Chapter of Bankruptcy is right for you.
2-A

.

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

n attorney will advise you on exactly which documentation you will be required to present to the court at your hearing.
3-Your at

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

Companies that provide selfless information through particip

orney will provide you a list of creditors that can and cannot call you to collect money due to them once you have filed for bankruptcy

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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Advice You - Reasons Why You Need a Bankruptcy Attorney

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