Advice You - Finance

While bankruptcy seems like an easy way out for some people there are a lot of things t

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

o consider before you file bankruptcy. The process is not always the same and it depend

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

Examples of combination products may in

on who is actually filing. If a person or an individual files bankruptcy the process 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.

completely different than if a business files for bankruptcy. For example, a business

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

annot even file for Chapter 13 bankruptcy. Instead the business must file a Chapter 11

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

Combination pro

ankruptcy.

A sole proprietorship must file Chapter 11 also. However, if an individual

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

who owns a sole proprietorship files bankruptcy, they may file under Chapter 13. They w

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

uld then take on the business related debts which they are personally (and legally) res

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

onsible for.

In order to file bankruptcy under Chapter 13, the individual must have a

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

teady earnings or else they will not qualify. A steady income is income that will alway

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

occur at regular intervals (daily, weekly, monthly, quarterly, semi-annually, or annua

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

Following aspects would a

lly). Your normal salary or hourly wage can fund a Chapter 13 bankruptcy. To get a good

dd to the challenges in developing combination products:

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

idea of what type of steady income qualifies, here are some examples: commissions from

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

ales, disability, unemployment, worker's compensation, self employment, child support,

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

nd real estate.

The individual who will file bankruptcy needs to be able to support 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

mselves on this steady income. This has to cover your daily needs and anything that is

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

Professional from academic institutions, pharmaceutical industries, health care indust

necessary to survive. The individual must also have some money left over each month. Th

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

s money is used to pay off the remaining debts they have. This is a lengthy process tha

.

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

can go on for a few years. The amount that must be paid each month is different for ea

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

Companies that provide selfless information through particip

h bankruptcy case. The total amount of debt the individual is in will play a large role

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 - File Bankruptcy (Chapter 13)

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