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What keeps you from following your dreams, from maybe even having dreams or from doing and being your best? Can you fee

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

l the fear by the tension in your shoulders or neck or your upset stomach or at 3:00am as you toss and turn and play tho

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

Examples of combination products may in

se what ifs from your last relationship over and over and over again in your mind. So how do you deal with your fear?

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 you constantly worry? Maybe you’d love to fine the shut off valve for all those thoughts running around in your head:

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

fear of what other people think, fear of losing a job, fear of not being good enough, fear of being rejected, fear of be

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

Combination pro

ng committed, fear of being in over your head, fear of being alone, fear of being smothered or controlled by another per

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

son.

Fear keeps us frozen, afraid to alter our course or to try something new. Fear keeps us numb and from being our b

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

est. Many of us are not aware of our fears. We have long ago stopped questioning them. Instead we just think that’s h

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

w life is. We may not even think a better life is possible or that we are even worthy of a better life. Fear can keep 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

ou paralyzed from making decisions or fear can force you into making a decision long before you are ready to do so.

Fai

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

h is the opposite of fear. Faith is a belief in the abundance of the universe. Faith is a belief that God loves us and

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

Following aspects would a

wants the best for us. God created us and God does hear out prayers. Faith is also a belief in our own capability to

dd to the challenges in developing combination products:

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

believe in ourselves and to work towards what we want.

Fear is about scarcity. Everything is in short supply and I pro

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

ably won’t get what I want. The more you tend to bring your fear in the light: to acknowledge it and to share it with o

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

thers the more it seems to disappear. Try writing a list of all your fears no matter how large or how insignificant. S

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

are your fears with a friend. Sharing your fear with another whom you trust, means you no longer have to deal with your

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

Professional from academic institutions, pharmaceutical industries, health care indust

fear alone. As a therapist I work with people whose fears as so great that they may feel out of control of their life

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

or so overwhelmed by fear that they find little enjoyment in life.

The more we fear the more stuck and limited our worl

.

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

becomes. As our faith in God’s abundance and love increases, we often find more abundance and love in our own lives.

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

Companies that provide selfless information through particip

How do you start each morning, with your focus on fear or faith? Where would you like to put your focus?

Copyright 200

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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