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'Live your life at the campfire' says Brandon Bays (The Journey), meaning that we

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

do not need to wait years to deal with issues but rather deal with them right here in the now. When

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

Examples of combination products may in

ver you are ready to let go of stored emotions, empty out all the past pain and come to a place whe

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 complete forgiveness is possible -- let it happen! Your life will provide you with enough opportu

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

ities to learn, understand, and let go - WHEN you do each step is your choice.

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

Combination pro

trong>How do you ‘Speak the Truth’?

In relation to people we always have situations happe

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

that leave emotional scaring. As soon as this is realized it is time to deal with it: If it is app

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

opriate going back to the person and emptying out and speaking about what is really here is one sol

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

tion. You will find that sentences that use the model of owning your feelings (‘I feel … because …’

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

) bring far more resolution than the blaming statements (‘you make me feel …’ and ‘it’s all your fa

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

lt…’).

The other solution is creating a campfire in your imagination. Invite the people involved i

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

Following aspects would a

the situation and imagine a conversation taking place between them. Once everything has been said

dd to the challenges in developing combination products:

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

nd there is a sense of completeness you are ready to ask for and offer forgiveness.

What’s

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

the benefit of ‘Speaking the Truth’?

Speaking the Truth allows you to travel light. The

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

rocess of clearing blocks, unloading baggage and letting go of resentment or hurt allows you to be

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

pen and present in the NOW. How often do you spend your time thinking about what happened, what you

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

Professional from academic institutions, pharmaceutical industries, health care indust

should have or could have said or trying to find someone to blame? What would you do with this valu

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

able time if you did not know how to hold onto those issues and where able to deal with them in a c

.

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

nstructive way?

Heaven is not a place out there
It is an inner state of presence
Awarene

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

Companies that provide selfless information through particip

s of NOW
So there is nowhere to get to
Nowhere to arrive
You are home – Welcome home

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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