Answers - Legal

Today, you can be in a better financial position if you rent a house instead of b

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

uying a house. Now it is possible to own you dream house at a very low cost and

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

Examples of combination products may in

onthly payments.

For example you buy a house for some X $. For getting a loan of

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

that size, you need a down payment up to 20% of that amount. Part from that clo

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

ing cost, appraisal, survey and originating fees has to be paid. And when you a

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

Combination pro

ply for a loan, several other fees have to be paid. So when it is the time of cl

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

osing, you are generally out of pocket.

Now for example, after three years, supp

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

se the market value of your property does not get increased, then all the money y

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

u paid at closing time is equal to equity of the same amount.

Now try to imagin

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

e another situation. You buy a house and after a few years the condition of the

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

arket becomes good. Then you can easily sell the house in case you get a good buy

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

Following aspects would a

r.

You sell your house at a higher rate and go to another good house. Then you t

dd to the challenges in developing combination products:

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

hink you have made enough money and why not always buy a house and sell that when

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

the market condition is good. But, here also we like to mention that all the mon

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

y that you make during this period will be approximately equal to the money of eq

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

uity.

And lets have a look at the down side. You buy a house and after some time

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

Professional from academic institutions, pharmaceutical industries, health care indust

the market drops by say 10%. So, your house is quite hard to sell now and you do

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

ot get the right amount of money for it. Well, if you lease a house, it becomes

.

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

a winning situation here.

So, now you have seen what are the aspects related to

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

Companies that provide selfless information through particip

t. You should think over this before you are actually going to take some decision

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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