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The plane crash in Manhattan on October 11th, 2006, certainly did not recapture the horror of five years ago, but at first impact, it was a stunning reminder. The sentiments in the following article continue to be useful, and I feel th

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

at ground zero and all that occurred there and all the lives that were shattered at that time still deserve our compassionate concern. This is what I wrote at that time:

I had earmarked Tuesday morning, September 11th, to complete thi

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

Examples of combination products may in

column. For weeks I'd been jotting down thoughts and this was to be the time to collate them. At the top of the page I had scrolled the word "Imagine," and my first musings had been some of the key words in John Lennon's song:

Imagin

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

e all the people living for today
Imagine all the people living life in peace
Imagine all the people sharing all the world

There were other notes all aimed at using our brilliant imaginations to create more beauty and

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

ulfillment in our personal lives and ever expanding love and peace in our world.

And then it happened!

In certain circles John's song wasn't, and still isn't, well received. His lyrics speak of imagining no countries -- no religions

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

Combination pro

-- the very source of identity for many of us. But John's whole thrust here, it seems to me, is encouraging us to be here now -- today -- with peace in our hearts and love in our minds. To share this world openly, freely, and with grea

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

delight. No more separation -- no more arrogance that declares, "I'm better than you because I belong to this religion or live in this country.

"The truth is that we are family on this tiny, precious planet and he knew that. He knew

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

that "we are all one." And anything that obscures, denies, or defiles that innate connection and brotherhood is counterproductive to the natural flow of life.

If you're reading this column it's no accident, and you've got work to do.

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

e all do. This is why we're here now. Certainly we have to search our hearts for ways in which we can be helpful to our fellow beings and move forth to do that. But most of all, we need to Imagine.

On Friday evening, Sept. 14th, 2001

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

all over this country and in many parts of our world, candles were lit in an outpouring of spirit that sent light forth into the darkness. We can be doing that with our thoughts constantly. Light literally emanates from us when we thin

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

upon love and peace and all the positive energies.

So begin today to imagine that you are a bearer and beacon of light. See and feel that light is emanating from the center of your chest, what is metaphysically referred to as your he

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

Following aspects would a

art center. Imagine it like a gigantic search light, and focus it wherever you choose. (You can do this anywhere, anytime -- walking down the street, sitting on the bus, doing the dishes, making the bed, etc. You don't have to be at a

dd to the challenges in developing combination products:

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

rayer meeting or in meditation.)

Also imagine that the light of compassion is pouring from your eyes everywhere you look and that light flows from your hands healing everything you touch. Imagine your "heart search light" flowing into

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

those who are grieving the loss of loved ones and profoundly comforting them. See it descending upon ground zero, assisting the courageous beings who are working there with such relentless determination. See it blessing and releasing

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

he suffering of those who so abruptly lost their lives. See it bringing hope and new vision to those whose lives have been so drastically shattered. See it filling the hearts and minds of all our world leaders with inspiration and grea

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

t wisdom at this most critical hour.

Imagine that you are sending forth light to encircle our earth and rain down a soothing balm that, now and forevermore, heals the anger and hatred that source such egregious acts. Imagine.

Imagine

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

Professional from academic institutions, pharmaceutical industries, health care indust

that this time we finally wake up; we get it. Imagine that this time we recognize and claim that the love, the beauty, the deep compassionate caring that become our modus operandi in times of great crisis is who we really are. Imagine

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

that this time we shift into that way of being, always.

Imagine that this is the catalyst that transforms the consciousness of the entire planet. "Imagine all the people sharing all the world" in love, harmony and understanding.

Albe

.

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

t Einstein said that imagination is more important than information. Imagine that your mind and heart and every fiber of your being is a healing instrument. It is when you say so. Be the Light. Imagine.

Whenever in doubt, Come Home to

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

Companies that provide selfless information through particip

you Heart Elizabeth Hepburn ~ http://elizabethhepburn.blogspot.com or http://www.elizabethhepburn.com

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Is marketing one of the last bastions of unregulated expenditure within a business? There is growing pressure from the Boardroom and Executive Management Committee's to bring marketing and communications expenditure to heal. However, this is more fundamental than simply requiring the Marketing Director to take an obedience class.

High real estate prices, paper gain and general over consumption do not tell the whole story of why the rate of personal savings in American has dropped below zero. The real reasons go much deeper but remain hidden in the background.

Many scientists have expressed concern that hard exercise damages muscles, so it may turn on inflammation and thus increase heart attack risk. A recent study shows that this does not happen. Read on to understand the latest research on benefits of vigorous exercise to reduce heart attack risk.

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