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"In the sixth century of the sixth millennium, the gates of supernal [heavenly] wisdom will be opened, as will the wellsprings of earthly wisdom, preparing the world to be elevated in the seventh m

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

illennium." The Zohar (a source text of Kabbalah)

TRY SAYING THESE WORDS TO YOURSELF:

Depressed, sad, afraid, guilty, alone, weak, fragmented, disconnected, weary, helpless, victimized, threa

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

Examples of combination products may in

ened, tired, drained, resentful, unappreciated, misunderstood, burdened, angry, hate, hard, not good enough, dreary, stupid, ugly, lonely, impossible, overwhelmed, isolated, too much for me, failur

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 can’t, danger, panic, it’s too hard…

How do you feel? And, what happens to your goals when you feel this way? To your energy? To your willingness to take risks? To your belief in yourself 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

your dreams?

It’s not such a pretty picture.

NOW TRY THESE:

Happy, overjoyed, energized, strong, delighted, proud, empowered, flowing, intimate, ease, rested, fresh, possibility, connectedness,

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

Combination pro

rust, openness, aliveness, love, awe, greatness, authenticity, harmony, success, safe, free, just right, excellence, beauty, pleasure, joy, power, creative, wholeness, shimmering, I have what it ta

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

es, I can do it, it’s a breeze….

Feel any better? Ready to get going again?

This simple but powerful exercise is designed to give you a tiny taste of the power of words. WORDS CREATE! The words 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

e use (whether in speech or thought) play a central role in generating our perspective and feelings. Our feelings generate actions and our actions generate results. It all starts with words.

WANT

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

O KNOW WHY IT WORKS THIS WAY?

G-d created the world with words. According to Kabbalah, words and letters are the actual building blocks – the raw material - of creation. Everything has a Hebrew na

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

e, and each letter of that name is a channel for a specific Divine energy. The energies of these letters and the way they are combined determines the particular unique characteristics of everything

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

in existence.

Before the words of creation were spoken, everything existed only in a primordial state of Divine ‘nothingness’ - infinite undifferentiated potential.

But when G-d said, “Let there

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

Following aspects would a

be light” (In Hebrew, ‘vayehi ohr’), these words became the creative force that brought into being what we know as light. The same thing applies to each and every detail of creation.

Creation, ho

dd to the challenges in developing combination products:

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

ever, was not a onetime event. According to Kabbalah, the words of creation are being ‘spoken’ by G-d continuously. Therefore, the world is being brought into being anew out of the Divine ‘nothingn

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

ss’ at every moment. In fact, the natural state of the universe is non-existence. If G-d were to stop ‘speaking’ the words of creation for even an instant, the whole universe would disappear as if

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

it had never been!

WHAT DOES THIS MEAN TO YOU?

As a human being, you have been invested with the power and the purpose to act as a partner in creation. And as such, you are invested with the same

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

extraordinary Divine power to speak your world into existence! You have the ability to create with your words; to start to bring into being what you truly want out of the infinite potential of you

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

Professional from academic institutions, pharmaceutical industries, health care indust

own soul. Just as the creation of the universe began with words and is sustained with words, so too every creative process. The words you use actually bring things to life – and when you stop usin

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

g those words, or change them, you will inevitably create something completely new.

Words of love create nurturing and connection. Words of praise inspire confidence and peace. Words of hope gener

.

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

te positive action. Words of encouragement bring courage into being. Words of vision cause the soul to come alive.

So choose your words with care – and let there be life!

© Shifra hendrie

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

Companies that provide selfless information through particip

target="_new" href="http://www.kabbalahoftransformation.com">www.kabbalahoftransformation.com

*Since the Torah forbids the erasing of G-d’s name, it’s customary to avoid writing it out in full

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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