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A new chapter in my life begins today, the anniversary of my birth. It is therefore necessary that I pause to reflect upon this past year.

For me, the intervening year between the last and this one

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

has been a buffet of different experiences. It has consisted of both blessings and burdens, delight and depression, ecstasy and agony, healing and hurt, plenty and poverty, success and failure, tri

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

Examples of combination products may in

umphs and temptations. But, through it all God has been good to me.

After looking back and cataloging my cares, enumerating my difficulties, adding up my victories, listing my heavy loads, summing

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

up my successes and tallying up my trials, it all equaled great joy. Somehow, God took my troubles and transformed them into testimonies. He took my pains and replaced it with perseverance. He took

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

my fears and strengthened my faith. He took my tears of hurt and turned them into tears of joy. Yes, when I calculated all the good, the bad and the ugly, it still equaled great joy.

James, the bro

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

Combination pro

ther of Jesus begins his book with a stunning command. He says: Brothers and sisters count it all joy whenever you face trials of many kinds. This is interesting because inherent in the advice in th

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

e need for us to be able to count. All Christians has to be able to count because God has incorporated counting as an integral part of His plan for the development of discipline and discipleship. So

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 tells us that we need to count and not only count but count it all.

It is in the all that we find deliverance. It is not counting only the blessings and victories, but we must als

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

o count the bad and the ugly; counting it all totals up to joy.

Now, here is the catch. Counting, in the context of our faith, does not start until troubles come. Actually, it can be likened to box

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

ing. The referee does not start counting until the boxer falls. It is the fall that begins the count. This is important to understand because God's joy cannot be experienced any other way.

We may n

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

ot want to acknowledge it or even desire it, but every Christian needs a trial or two. Every child of God needs sprinklings of tribulations. Every believer needs to experience the fiery furnace and

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

Following aspects would a

the lion’s den because that is when you begin to understand how God operates. That is when you begin to perceive how evil and good work together for your joy. Paul declared: “All things work togethe

dd to the challenges in developing combination products:

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

r for the good to them that love the Lord and are called according to his purpose”? You will note that he also included that significant word, all. It is not just the good or the bad; it is

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

the good AND the bad. When combined the result is joy, joy, joy.

Now, it must be understood that joy is a process and not a destination. We are constantly growing, changing, evolving, develo

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

ping joy every day. It cannot be made, created, bought or sold because it comes from God. Joy is not parading around pretending to be happy when you know you are not, thinking that is the way Christ

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

ians should present.

Joy is not instantaneous or immediate. It is not feeling giddy, silly or happy, as it were. Joy is much more profound. Joy is the product of pain and troubles. It is the result

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

Professional from academic institutions, pharmaceutical industries, health care indust

of suffering and distress. Joy is intrinsically connected with what you have been through or what you are going through. Joy is the outcome of faith and patience. It is a supernatural portion of Go

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

d’s peace and strength. Weeping may endure for a night, but joy does come in the morning.

I have learned that if you can pray it through, God will see you through. But do not start counting too soo

.

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

n. Remember, the count really starts when you fall into difficult circumstances. Then start counting:

1… The crises come.

2… What do you do?

3… You want to flee.

4… No escape door.

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

Companies that provide selfless information through particip

5… Will you survive?

6… You pray, “God please fix.”

7… You hear from heaven.

8… God said, “Wait.”

9… Here comes True Vine.

10… JOY WITHIN!

11…

Thank God in heaven.

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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