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Everyone should be allowed to practice the religion of their choice; there is no ri

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

ght or wrong, as it is all perspective based. Everyone should be allowed to have t

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

Examples of combination products may in

heir belief system and their culture and therefore I must kill you on behalf of my

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

peaceful religion.

You must accept this as that is what I believe in and how dare

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

you can damn me for my religion. You see I have no choice, it is written and I must

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

Combination pro

fulfill the wishes of my gods? Are these people serious? How can anyone sit back

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

and simply allow this to occur all in the name of religion? Have the leaders of t

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

he free world and the entire human race suddenly gone insane?

Obviously we have a

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

problem with world religions and human history has recorded this over the millenniu

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

ms. Unfortunately, we are not learning from our history or our mistakes and theref

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

ore we are doomed to repeat them. But to boldly march into World War III without s

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

Following aspects would a

aying anything about it and accepting the hypocrisy of the argument is simply baffl

dd to the challenges in developing combination products:

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

ing.

Humans never stop to amaze me with their rhetoric over world religions. Ever

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

y religion swears that it is right and the others are all wrong. Yet, the chances

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

are that no religion is correct and they are all wrong. But that is okay because p

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

eople are allowed to believe in something that is not so because it is their cultur

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

Professional from academic institutions, pharmaceutical industries, health care indust

e or it is their perspective.

Never mind that it is a falsehood and that all world

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

religions are based on fictitious fairytale literature used to enslave people of a

.

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

prior period. When will the human race wake-up and when will it become time to ba

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

Companies that provide selfless information through particip

nish all world religions from the present period. Please consider all this 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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