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I am sure you, just like the rest of us, experienced all sorts of day dreams when you were younger. Who amongst us did not find themselves, at one time or another, in the

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

precarious position of being blissfully lost in day dream when one of our teachers called on us in class? You know how that story went.

Caught completely off guard, hop

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

Examples of combination products may in

elessly lost in the tranquillity of the day dream, we would awaken to the teacher's raised voice, stumble or bumble out some sort of goofy answer and then proceed to turn

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

beet red with embarrassment as our classmates laughed at our lack of attentiveness. After being summarily chastised by our teacher and told to pay more attention and sto

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

p our foolish day dreaming, you would think that such an unpleasant event would serve as a permanent reminder to for us to quit day dreaming once and for all. Yet a few m

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

Combination pro

oments later, the teacher would catch us lost in a day dream once again.

Even as adults, the beat still goes on. Who hasn't caught themselves day dreaming at work when t

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

hey were supposed to be right in the middle of doing something else?

It is kind of weird, isn't it? When you day dream, your mind somehow drifts off into a whole other w

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

orld unobstructed from the rigors of your daily routine. Your mind, without your permission or conscious effort, conjures up all sorts of nice, peaceful and tranquil feel

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

ings. You are literally lost in the bliss and contentment the day dream offers when all of a sudden, BOOM!!! ... you find yourself wide awake and thrust back into the rea

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

l world again. With the day dream over for now, you experience a feeling of being let down. Why is that the case?

Whenever we day dream, our minds meticulously paint a b

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

reathtaking picture of the paradise we want our life to become. Isn’t it ironic how we have somehow been conditioned over the years to believe that day dreams are bad for

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

Following aspects would a

us and distract us from the business at hand? That is simply not the case. It is perfectly A-OK for you and me to regularly day dream, freeing our minds to fashion and s

dd to the challenges in developing combination products:

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

hape the game plans we need to turn our dreams into reality. Instead of feeling guilty about day dreaming when you should be working, why not plan your day dreams?

A gre

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

at time to let your mind wander aimlessly, without restraint or limitations, is during your ‘break’ times. Whenever you take a few moments to unwind and relax, you can at

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

the same time encourage your mind to paint a brilliant, dramatic, sensory rich day dream of the life you desire. Your mind, once turned on and turned loose, can almost o

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

ver power you with a spontaneous stream of emotion laden positive thoughts, ideas and images. Then instead of waking yourself up, you should let yourself go, totally imme

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

Professional from academic institutions, pharmaceutical industries, health care indust

rsing yourself in the beauty and splendor of the day dream.

I want you to see, feel, touch and live this beautiful picture in full detail. Can you see it? Can you sense

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

it? Doesn't it feel absolutely terrific to see yourself doing, being and having everything that you have ever wanted? You bet it does! And if dreaming about living the be

.

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

autiful life feels this great, just imagine how sensational it will feel to make these dreams a reality. I encourage you to have really big day dreams about really great

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

Companies that provide selfless information through particip

things. Then I want you to wake up and make these dreams come true.

The Bottom Line: Dream of your life like as it could be – then wake up and live it like it should be.

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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For anyone who would like to decrease their risk of death (most of us I imagine), there's a fairly simple way to make a massive improvement.

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