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At some point in time, you are going to have to get on that big bird and head to Russi

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

a. You can write letters until your correspondence file is thicker than War and Peace.

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

Examples of combination products may in

And you can telephone her until you feel you are paying enough to single handedly bri

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

ng MCI / World Com out of bankruptcy. And the result will be nil until you go to Russi

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

.

Why? Well, the first reason is that you cannot bring a woman to the U.S. under a fi

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

Combination pro

anc? visa without meeting her first, and providing substantial proof of that meeting.

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

Secondly, you have a better chance of winning the state lottery than she has a chance

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

of getting a tourist visa to America. Unless she can provide ‘overwhelming evidence’ t

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

at she will return to Russia, the U.S. Government will not issue her a tourist visa.

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

‘Overwhelming evidence’ is evidence that she is leaving her children or substantial pr

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

perty in Russia, such that she would not risk losing them by not returning to Russia.

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

Following aspects would a

Very few, if any, women you are likely to meet in Russia are going to qualify under th

dd to the challenges in developing combination products:

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

s criterion.

You will find unscrupulous tour agencies that say they will get her a to

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

urist visa, but they are lying. There is no such shortcut. They will take your money a

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

d you will never hear from them again.

The long and short of it is that YOU must go t

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

o Russia if you are to bring home the woman of your dreams.

This is not as unpleasant

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

Professional from academic institutions, pharmaceutical industries, health care indust

as it may seem. You will have the opportunity to meet hundreds of beautiful women. You

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

will find traveling to Russia an experience that you will not soon forget.

I discuss

.

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

the details of traveling to Russia in more detail below. However, there are two basic

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

Companies that provide selfless information through particip

ways of traveling: by yourself and with a tour. I will discuss traveling by tour first

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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