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You have probably noticed some announcements informing the public that company or orga

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

nization is already bankrupt. The daily news could also contain news that a company or

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

Examples of combination products may in

even a person is filing for bankruptcy. Informing the public of someone’s bankruptcy 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.

more of a legal obligation than a ploy to humiliate the company or person further.

C

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

mpanies, businesses, or organizations are not the only ones who could go bankrupt. A p

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

Combination pro

rson or individual could also fall into bankruptcy. This happens when a person is unab

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

e to pay his debts, bills, and other financial obligations when they are due. And just

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

like bankruptcy in companies, businesses, and organizations, there are various reason

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

why a person is in this kind of situation.

Most people who go into bankruptcy could

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

ile Chapter 13 bankruptcy. In Chapter 13, a person who is from the United States can t

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

y to reorganize and restructure his financial situation. Just like Chapter 11 bankrupt

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

Following aspects would a

y, which is for companies, Chapter 13 provides the person or individual with the oppor

dd to the challenges in developing combination products:

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

unity to start anew and sort out his financial situation. This is done with the superv

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

sion and approval of the bankruptcy court.

When a person or individual files Chapter

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

13 bankruptcy, he has to show the bankruptcy court a plan of action as to how he would

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

be able to pay off his creditors. This should be done in a maximum of three to five ye

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

Professional from academic institutions, pharmaceutical industries, health care indust

rs only. The person pays off any debts, as much as he can, in regular intervals. When

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

person or individual has already filed under Chapter 13, he is then protected from hi

.

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

creditors’ efforts at making him pay for the debts acquired.

A person’s credit repor

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

Companies that provide selfless information through particip

reflects and shows his bankruptcy. This information is kept for a period of ten years

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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