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Growing up, as a child of the 60’s, peace, love and harmony were the words being chanted by the hippies, flower children and all who questioned authority and were against the Vietnam War. I remember thinking how I couldn’t wait to grow up. I knew in my young mind it was only a matte

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

r of time before these youthful rebels would age and mature and eventually be able to take their place in the world of politics and public opinion. With it, they would be able to change all the things they saw wrong with the “establishment” from a place of power and influence and not

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

Examples of combination products may in

from the streets.

I recall my excitement, thinking what a wonderful world it will be, knowing that these brave crusaders were blazing a trail before me, their radical new views and opinions becoming a reality. And at that young age, I recognized I would be the first generation to r

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

eap the benefits of their efforts. I felt blessed to be born in such a historic time.

Wow, was I wrong.

Often I ask myself, where have all the flower children gone? Where are the young men and women who fought for life, liberty and the pursuit of happiness? Where are the people w

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

ho burned flags, bras and draft cards; who marched on college campuses and on Washington DC so their voices could be heard? I find it hard to believe the thoughts and values they fought so valiantly for have disappeared and are only a fond memory of a golden age gone by.

Over the pa

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

Combination pro

st few months, this point has become painfully obvious. As I work with clients and talk with friends I hear the sound of hopelessness in their voices. They watch as gas and food prices soar. They gaze in disbelief as senseless violence escalates. They stand by helplessly as their

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

jobs are moved overseas and their personal freedoms are taken away one-by-one. In the end, they are left feeling impotent because they are unable to control the path their lives are taking and feel powerless to change it.

It’s interesting, because on an individual basis, all we want

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

is to be happy, healthy and live our lives in integrity. We want to know that we will have a job to go to on Monday. We want to be able to feed our children, breath the air around us, drink the water and step outside our homes. Instead we have become increasingly alienated by the

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

harsh reality of our world, a reality which creates conflicts between how things are and how we would like them to be. Thus we end up feeling dissatisfied and give up all hope of a better, simpler life.

Hopelessness is a hard emotion to experience; one we have embraced at some point

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

in our lives. It seems to happen just before we hit rock bottom, when we can’t see the light at the end of the tunnel or when life seems futile and we just want to give up. It is a natural part of the human condition.

Over the last six months, the feeling of hopelessness has becom

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

e overwhelming for many of us. Every time we turn around there’s a crisis. Someone we love dies, we loose our job or our child falls ill. After the situation we are facing is handled, it isn’t long before another challenge steps into our lives and once more the drama begins anew.

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

Following aspects would a

With this unrelenting pressure, we are left feeling tired and disillusioned - transforming the most optimistic person into a pessimist.

Today, the pressures being experienced are not only coming from our personal lives but also from a much larger community - the world of big business

dd to the challenges in developing combination products:

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

and the political arena. As we watch what is going on in the world we may think “What can I do to change or affect what is going on?” Unfortunately, in our state of hopelessness, the answer we receive is “nothing”.

Because we believe our lone voice will never be heard, we end up c

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

onceding to the futility of fighting the establishment. And in our sea of inner disquiet we realize that we are being coerced into accepting a system which does not support us and the greater good of society. It is from this perspective that we surrender our power and feel we are un

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

able to bring about change.

It is said, that it is always the darkest before the dawn. For many of us, the truth is we cannot even see the light at the end of the tunnel. We are living in the midst of darkness, hoping and praying for even the faintest glimmer of light to emerge. A

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

nd so while this period in human history may not be fun, there are many blessings that will come from it.

The good news is hopelessness causes us to go within. It forces us to reflect and evaluate our lives. It provides us the opportunity to uncover steps necessary to alter our lif

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

Professional from academic institutions, pharmaceutical industries, health care indust

e course. As a result, we find a strength which helps to build our inner resolve and restore our faith.

We also have to realize that we are not alone. There are countless millions who are feeling trapped, hopeless and at the end of their rope. What the “Powers-That-Be” don’t reali

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

ze is that it is only a matter of time before they push us far enough into a corner that we will have no choice but to take a stand. When that happens, it won’t matter what they say or want us to do. When we determine enough is enough the strength of our unity as a whole will make a

.

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

difference and a change will begin on all levels.

So for all of us, the sick, the tired, the forlorn, remember…It’s just a matter of time. Things can’t keep going the way they are. Change is inevitable. So whether today, tomorrow or next year, we must let the light shine into our

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

Companies that provide selfless information through particip

darkened tunnels to lift the veil of hopelessness and despair. With this newfound sense of hope, we will be able to walk peacefully through the darkest of night. We will find through our renewed courage, fortitude and sense of self that we will be able to create a world of change.

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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