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1. First and foremost, ask yourself, “Do I even need a bankruptcy lawyer to file my case?” If your c

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

ase is fairly straightforward, then chances are you can get a bankruptcy petition preparer to file yo

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

Examples of combination products may in

ur case for much less than the cost of hiring a lawyer. Despite popular conception, bankruptcy law i

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

not very complicated, so hiring an expert most of the times does not make sense. The real question

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

then becomes, “How complicated is my case?” In short, if a) you have 100 percent unsecured debt (cre

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

Combination pro

it cards, medical bills, personal loans, repossessions, etc.); b) you’re unemployed with no assets (c

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

ar, home, brokerage accounts, etc.) and c) you did not accumulate the debt very recently or in any wa

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

y that can be construed as fraudulent (i.e. buying a big screen TV on a credit card a month before yo

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

filed) then you may not need a bankruptcy lawyer to file your case.

2. If your case is more

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

complicated, then will you receive the sort of personal attention that you deserve in order to have

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

our case properly handled? A lot of bankruptcy firms are devoted to basic filings, and you will rece

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

Following aspects would a

ive little to no attention from your actual lawyer. With this much at stake, it’s important that you

dd to the challenges in developing combination products:

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

deal directly with a professional that is an expert in bankruptcy law.

3. Get a referral.

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

If you know someone who has filed bankruptcy, don’t be afraid to ask them whether they felt their la

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

wyer handled their case well. If you don’t know anyone who has filed bankruptcy before, then call a

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

aw firm outside of your area and ask for a referral from them.

4. Shop around. Most bankr

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

Professional from academic institutions, pharmaceutical industries, health care indust

uptcy lawyers will at least offer a free initial consultation. Find a lawyer that you feel comfortab

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

le discussing your personal matters with and who offers a competitive rate for their fees. Remember

.

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

ot to compromise quality and experience just because a bankruptcy lawyer offers lower fees, however.

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

Companies that provide selfless information through particip

Contact your state’s Attorney General office for a suggested list of bankruptcy lawyers in your area

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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