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The Law of Attraction is something I’ve always known but as I have become aware of how

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

it works what a change in my life. It has impacted every avenue of my life. Learning

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

Examples of combination products may in

o be grateful has been the biggest obstacle. How can I accept the growth and knowledge

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

I have acquired and not get so wrapped up in what I don’t have? Wow that blew my mind

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

All of the obstacles in my way were of my own doing. Again I was knocked for a loop.

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

Combination pro

This awakening served me well.

When you awaken the world becomes your giant storeroom

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

with all you desires in front of you. You control when, how and how fast you achieve t

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

hem. That is power. Soak that in. You create your own destiny. Thoughts become things.

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

Well what do you want? Is it in alignment with your present path? Are you willing to

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

take the steps to obtain it? It's all in your power. Look inside and make a clear pict

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

re of exactly what you want. Yes exactly! Not just I want a Hummer, but rather I will

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

Following aspects would a

have a 2007 Grey Hummer with every gadget known to the car industry in the next 6 mont

dd to the challenges in developing combination products:

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

s. Be specific as possible. Feel the feeling. Live in the moment of reveling in the be

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

auty of your imagination.

Whatever your faith this is a simple truth. Man is an incre

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

ible creation with unlimited potential in his grasp. That power to change the world is

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

in your hands. You control your own destiny! How do you wish to use this power? Is it

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

Professional from academic institutions, pharmaceutical industries, health care indust

to mire in your own obstacles or is it to overcome those challenges and inspire the mu

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

ltitudes? What legacy will you leave. Mine will be one of great growth for the entire

.

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

uman experience. Do you align with that? What will you do to foster good will in plane

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

Companies that provide selfless information through particip

t Earth? The power is in your hands use it wisely!

THE SUN NEVER SETS ON OPPORTUNITY!

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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