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I have been told by my liberal friends that they are much smarter than I am because t

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

hey hold the keys to understanding the world better. This is wonderful I thought 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

I decided I wanted to be just like them. In discussing world matters, business, pol

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

itics, the flows of civilization, history, science, humanities and so many other wort

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

hy topics; I found interesting conversations with a skewed perception of course.

Unf

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

Combination pro

ortunately I found out I did not qualify to be a Liberal because I lived in reality a

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

nd I paid attention to my observations and I understood the world. Having been succe

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

ssful in business, politics, sports and other various activities I found that my obse

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

rvations were not welcomed with my liberal friends. They were not interested in my k

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

nowledge or experience. Instead they told me that I was intellectually inferior to t

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

em. But luckily they would set me straight so they made me listen and it then recite

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

Following aspects would a

what they had said.

But still I could not forget the truth or the reality of my obs

dd to the challenges in developing combination products:

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

ervations in the real world and refusing to forget my memory I am not allowed to be a

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

Liberal. The Liberals also said that there are certain things I cannot say even tho

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

ugh they're the truth. Each time I would say something even if it was the truth I wo

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

uld be called unprofessional and anyone who is deemed to be unprofessional is unworth

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

Professional from academic institutions, pharmaceutical industries, health care indust

y.

Those who are unprofessional are not allowed to be liberals. In fact, I found th

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

at I could someday make the grade and be a Liberal if I were to just be like everyone

.

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

else and stop telling the truth. So I am working on that now because I want to be a

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

Companies that provide selfless information through particip

Liberal just like them. I hope to complete my training soon. Consider that in 2006

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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I Suggest - I Want to Be a Liberal

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