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There is no incident in the life of Moses which I consider more epochal than this one; the encounter with the Red Sea. Here was a man who was faced with a great dilemma.

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

He was on his way from Egypt to Canaan. He had received instructions from God to take the journey and he was following orders. He had been chosen to lead a group of oppres

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

Examples of combination products may in

ed and downtrodden people to the Promised Land. The journey had been successful to this point. Two great pillars had formed in the sky to lead them: a pillar of cloud by d

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

ay and a pillar of fire by night. It was a wilderness journey.

It was a wilderness journey because God led them not by way of the land of the Philistines, which geographi

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

ally would have been closer to the Promised Land, but rather, God led them through the wilderness of the Red Sea, the longest and most difficult route. This seems to sugge

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

Combination pro

t that when God gets ready to build the strength of a people, He uses His own strategy. He does not do what we think He might have done or should have done, He does what i

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

s best. No man can tell God what to do or how to do. He led them through the way of the wilderness and the Red Sea and crossing it gave Israel a history as long as the ag

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

s. This one incident stamped eternity upon the people of God.

Well, it has been said, and I believe, that the easy way out in life is never ultimately profitable – even t

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

hough it may appear to be. The short and easy way only leads to a fools’ haven; a place where we feel we have arrived only to discover we have missed the mark in life. We

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

cannot understand or face life until we have walked the rough and rugged paths; when we have tasted the bitter cup of oppression and persecution. We cannot understand life

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

until we have been confronted by trials and tribulations, heartbreaks and desperation. We can never grasp what life is really about until we have walked through the wilder

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

Following aspects would a

ness and crossed the high waters of troubles. Great nations and great individuals have been burned out of struggle and bloodshed.

God led His people through the wildernes

dd to the challenges in developing combination products:

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

- not to punish them, not to get even with them for their disobedience, but to equip them to handle the difficulties that were ahead of them. God is like that. Sometimes

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

He will lead us through the wilderness to prepare us for some obstacle that lies ahead. He prepares us for victory over major trials. And I kind of like the way God does b

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

siness because every now and then in my personal history, major events come my way and when these especially difficult challenges come, I want to be able to stand.

God ne

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

er leads an individual around opposition but through it – straight through. In both the Old Testament and the New Testament, we find God leading His children through and n

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

Professional from academic institutions, pharmaceutical industries, health care indust

ot around opposition. When these Hebrew children looked to the east, they saw the Red Sea; when they looked to the west and south, they saw huge mountains, and to the nort

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

of them was Pharaoh’s army in host pursuit. You remember the story. God told Moses to tell the Israelites to “Go Forward” and He provided a way for them through
.

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
i> the Red Sea. God never leads us into a wilderness and leaves us. If He takes us in, He will bring us out if we trust Him.

God never tells an individual to quit. He
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
has one command, Go Forward. It is the only means of getting ahead. Canaan is always out in front of us. It is more that a place, it is God’s destiny for men

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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