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" Teach your children what we have taught our children--- that the earth is our mother. Whatever befalls the earth befalls the sons 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

daughters of the earth. If men spit upon the ground, they spit upon themselves.

This we know, the earth does not belong to us, we belon

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

Examples of combination products may in

g to the earth. This we know, all things are connected like the blood which unites one family. All things are connected.Whatever befal

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

ls the earth befalls the sons and daughters of the earth. We did not weave the web of life, we are merely a strand in it. Whatever we do

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

to the web, we do to ourselves."

Chief Seattle was born in 1786 in what is now the state of Washington. He became a convert to Catholi

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

Combination pro

ism and pursued the path of a peaceful co-existence with the white settlers. The city of Seattle is named after the chief. He was an ora

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

tor, peacemaker and an enlightened man. I had heard the message about my connection with the earth so many times over my lifetime, but

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

it never really made any sense to me. Sure, I was living on this rock called earth, but it was just sitting there in space, in a solar

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

system that was a mystery. I could do what I willed with it and it would always be what it was, a rock sitting in space. Of course, the

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

ignorance of my thinking has become obvious as the Chief said, everything is connected.

Through my education I learned everything was d

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

fferent. Different meaning not connected. I was different from people, places and things. My only connection was believing the thoughts

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

Following aspects would a

of someone else in order to conform to a judgemental way of knowing. Then I had an identity to relate to. I had a religion, a political

dd to the challenges in developing combination products:

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

or social position to view the world where I existed. I still had no idea that what I called inanimate objects, were as alive as I was.

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

The earth, that rock, was filled with life and I was part of it. It took many years for me to remember why I was living this dream.

I a

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

m what the earth is. A whole part of another whole. I am connected to all life, and what I believe I become. I believe I impact my world

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

through my thoughts and I change constantly. I am here to become a grander version of myself by being aware that I am fueled by love.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Earth's love, universal love, Source Love. I am experiencing this life with free will and free choice and to offer unconditional univers

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

al service to all things.

This I know, I am a spirit having an human experience. This I know, earth is my mother. This I know, I am her

.

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

e to Love, not to hate. This I know, I am connected to all life and whatever I do to it, I do to myself. Now I can accept my ignorance

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

Companies that provide selfless information through particip

and release it. Now I can be the change I want to see. Today on Memorial Day, I can feel the presence of peace within me and express it

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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