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A perfect example of this phenomenon is a real-life situation of a divorcee. The borrower was a teacher who was recently divorced. She lived in a $280,000 home,

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

and the mortgage was covered by her ex-husband. After the divorce, the teacher remained in the house, but she couldn’t afford the house payments. Within a few

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

Examples of combination products may in

months, she found herself facing a foreclosure. She contacted a lender to try to refinance the home in order to keep the house. Unfortunately, her debt ratio wa

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

s so “out-of-whack” that she wasn’t able to get a loan, even though her credit was perfect (the delinquent mortgage was on the ex-husband’s credit).

Your credi

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

t history has much to do with your debt ratio as well. If you have absolutely perfect credit, you might qualify for a no-income-verification loan. For this type

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

Combination pro

of loan, the lender will use whatever income figure you supply. If you make $12,000 per month selling figurines on ebay, you can enter $12,000 for your income

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

on your application, and the lender will not ask to verify it. The reasoning behind this is that if your credit is perfect and your scores are high, there is an

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

inherent assumption that you know how to manage your money. Therefore, you know what you can afford. Usually, you will need a credit score of at least 700 to q

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

ualify.

You might ask, “What about the divorced teacher? She had perfect credit – couldn’t she have qualified for a no-income loan?” The answer is it depends o

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

n the lender. In most cases, no-income-verification loans apply to self-employed borrowers only. The teacher was not self-employed. Further, lenders apply a rea

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

sonability test. It would be unreasonable to expect a teacher to make a salary high enough to support a $280,000 house.

You don’t have to have perfect credit f

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

Following aspects would a

or a no-income-verification loan. Most subprime lenders will also offer a no-income-verification product. You can have a score as low as 580 and qualify for a n

dd to the challenges in developing combination products:

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

o income loan. However, the interest rates and fees can be exorbitant for the subprime version of this product.

Before applying to a lender, analyze your own s

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

ituation. Obtain a copy of your credit report from the three major credit bureaus so you can see what accounts the lender sees. If the account is not listed on

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

the credit report, chances are it won’t count against your debt ratio. In any case, by analyzing your credit reports, you can calculate your own debt ratio, wit

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

hin a reasonable degree of accuracy. Add up all of your verifiable income for every borrower listed on your application. Then, add up all of the accounts showin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g up on all credit reports. Divide the debts by the income.

Your best bet, regardless of your debt ratio, is to make sure your credit scores are as high as pos

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

sible. Whether you plan on taking advantage of a no-income-verification loan or not, when you have high credit scores, you have more options available to you. Y

.

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

ou will garner more leniency when it comes to debt ratios. Lenders will either grant you debt-ratio exceptions, or will lower your rate to fit a debt-ratio. Eit

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

Companies that provide selfless information through particip

her way, you will get the best rates available when your credit scores are high. Lower rates give you a better chance of fitting into most debt-ratio guidelines

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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