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What a joy it is to see the signs of spring! Today my attention was drawn to the daffodi

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

ls. Seeing the daffodils brought to mind the fruit of keeping the Sabbath. The daffodil

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

Examples of combination products may in

bulb lies deep in the ground, undisturbed and spouts into full bloom in early spring, af

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

ter resting in the Sabbath. Mostly I think of things coming into full form in the autumn

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

. But the daffodil reminds me that although things seem to be lying dormant, everything

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

Combination pro

necessary for it to come into full bloom is taking place. God is still being God.

Life

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

is always bringing forth more life, whatever the season. Winter seems to be dark, cold,

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

and barren, but it is a Sabbath period. Last week I thought of writing about planting ne

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

w seeds, it seemed like a natural thing to do. But here is what came up for me today. Se

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

eds are always being planted and they come up in their own time, but they must go throug

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

h a Sabbath.

Yes, springtime is a great time to plant new seeds, but don’t forget the w

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

Following aspects would a

onderful expectation that comes from knowing that Life is always acting upon itself to b

dd to the challenges in developing combination products:

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

ring forth something fully formed. I need the times of seeming barrenness and darkness i

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

n my life, when I no longer think I know what to do. It is only then when I allow Life t

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

o act upon me, just like the daffodil. I get out of the way and realize that God is stil

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

l being God, without the need for me to direct the process.

I’ve stopped judging myself

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

Professional from academic institutions, pharmaceutical industries, health care indust

when I am not trying to make something happen. The truth is that when I have the idea o

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

f something and accept it as mine, Life will act upon it and bring it into form. The daf

.

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

fodil bulb, as is also true with a seed, allows Life to act upon it. Are you willing to

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

Companies that provide selfless information through particip

sit with an idea, a desire, or a perceived need long enough to allow Life to act upon 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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