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God !

"My son will be brought up in a place where he will not even hear

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

about the word "God" !

This man was totally against the concept of God

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

Examples of combination products may in

He was very staunch in his belief that there is no God and all people w

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

o believe that God exists are fools.

He was a learned scholar and he de

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

ided to take his wife and son to a secluded place... deep inside a fores

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

Combination pro

.

He built a beautiful house inside the forest, in a place where nature

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

was in its extreme beauty.

The boy grew up under his father's guidance

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

learned all the skills which one has to learn and became a scholar hims

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

lf. But the word "God" and the concept was never ever taught to him.

"Y

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

ur lessons are over, my son!" the father said to the boy who was a grown

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

up now.

Next day, not being able to find his son inside the house, he w

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

Following aspects would a

ent out calling him by his name...

The son was there watching nature...

dd to the challenges in developing combination products:

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

"What are you doing here son?"

"Father, I am enjoying the beautiful na

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

ure... the open sky, the sun, the trees, the lives... everything in this

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

universe... and did you not teach me that I should thank anyone who show

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

rs us with wonderful gifts?"

"yes..."

"I am thanking the Supreme Being

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

Professional from academic institutions, pharmaceutical industries, health care indust

who has created this lively Universe, father".

"You and I have a name.

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

what can we name this Supreme Being?"

The father whispered "God!"

We h

.

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

man beings are used to this concept of giving a form and naming everythi

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

Companies that provide selfless information through particip

g that we come across in our life.

Is this how God got his/her name too

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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