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There are three important types of closing costs associated with buying and

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

refinancing. They are as follows:

• Interest

When the transaction on your

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

Examples of combination products may in

efinance is closed, it is most likely that there will be some outstanding in

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

terest due on the old loan. Say, for instance, if you decide to close the tr

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

nsaction on August 20th, when you made your last payment, there will be a tw

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

Combination pro

nty days interest due on the old loan and ten days prepaid interest on the n

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

ew loan!

Moreover, the first payment on the new loan would not be asked unt

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

l October 1st. This is because you have already paid all the interest of the

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

month of August when you closed the refinance transaction.

It is worth noti

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

ng here that as the interest is paid in arrears, a September payment would h

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

ve paid August's interest, which has already been paid in closing.

• Reconv

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

Following aspects would a

yance Fee

When the existing lender "reconvey" the collateral interest in yo

dd to the challenges in developing combination products:

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

ur property back to you through recording of a ‘Reconveyance’, the fee charg

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

d for the same is called as the ‘Reconveyance Fee’. This fee varies from $75

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

to $125.

• Demand Fee

Yet another fee that can be charged by your existing

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

lender is called the ‘Demand fee’. This fee is charged for calculating the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ayoff figures. Generally, this fee might run in the neighborhood of $60 only

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

Thus, these are some of the closing costs associated with buying or refina

.

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

ncing. Find out more about these closing costs in detail before taking the f

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

Companies that provide selfless information through particip

nal decision. Internet can provide you with a lot of information on the same

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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