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Are you fond of using credit cards? If you are then I know you are aware that you have to be careful when using them. I’m a

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

big spender and I often use credit cards to buy any item that catches my fancy. The problem is that I was getting so carried

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

Examples of combination products may in

away with my shopping that I did not realize that I accumulated close to $20,000 in debts. As a result of my spending habit

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

, I was having a hard time keeping up with paying my monthly bills. I was so worried with my predicament that when that new

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

laws for bankruptcies were being passed, I was tempted to file.

Since the deadline for filing bankruptcies before the imple

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

Combination pro

mentation of the new laws was approaching and I have yet to make a decision about filing, I decided to talk it over with my

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

usband. After a long discussion I decided that I would not do it. I realized that I have to take responsibility for being c

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

areless with using credit cards. My conscience just couldn’t bear taking the easy way out. I was disgusted when I heard that

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

a friend chose to file despite only having a few thousand in debts. They even have the nerve to purchase a brand new car an

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

to go on a cruise on some tropical island before they filed. Since they charged the car and the cruise, they were able to

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

enjoy them for free.

News about the passing of the new laws caused a 30% increase in the number of bankruptcies filed in 20

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

Following aspects would a

05. More than two million people filed for personal bankruptcies, making it the highest number ever filed in a one year peri

dd to the challenges in developing combination products:

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

d. Those statistics means that millions of people found themselves in deep financial trouble last year. A number of reasons

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

have been given for having severe debts including job loss, credit cards, and medical bills. Among them high medical bills s

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

eems to be the most frequent cause of huge debts. It just goes to show how important it is to have adequate health care. 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

ajor accident or illness can quickly put you into insurmountable debts.

Hopefully the new laws will be able to discourage p

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

Professional from academic institutions, pharmaceutical industries, health care indust

eople from taking advantage of filing bankruptcies. They should encourage people to be more responsible with their money. Fi

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

ling will not bail them out from spending money on unnecessary furniture or luxury cruises. On the other hand the laws can 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

so make it tougher for people who acquire uncontrollable debts from unexpected mishaps. Be more responsible with using credi

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

Companies that provide selfless information through particip

t cards and make sure that you keep an eye on your financial situation to avoid the complications of filing for bankruptcies

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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