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"Man's main task in life is to give birth to himself." Erich Fromm was born in Germany in 1900. He was an author, phi

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

losopher, and professor, teaching at Columbia, Michigan State, and NYU. His work had a deep impact on social and poli

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

Examples of combination products may in

tical psychology. As you can see from this quote he believed that each man was responsible for himself. He believed t

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

at freedom was an aspect of human nature. We either embrace it or try to escape from it, by using escape mechanisms.

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

Three of them being: Automation conformity, displacing the burden of choice from self to society; Authoritarianism, a

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

Combination pro

lowing oneself to be controlled by another; Destructiveness which is an attempt to eliminate others or the world as a

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

whole in order to escape freedom. It seems we fear freedom, the innate gift, we come equipped with in physical form.

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

Fromm does make some valid points when I stop and look at the structures that have been built in society. Certainly

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

all three of the escapes listed by him are in my everyday life. I do want society to make choices for me. I seemed 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

want to be controlled by laws and rules that restrict my natural state of well being. And I just have to turn on the

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

news or open a paper to see the destruction that I am creating around the world, then masking it with the pseudo voic

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

Following aspects would a

e of freedom. Fear is more the catalyst than freedom.

So this birth that Fromm talks about is really an awakening. A

dd to the challenges in developing combination products:

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

awareness of who I am. Realizing the precious gifts I possess innately, and using them to expand and grow. I can be

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

a positive part of society without giving myself away. I can contribute to the collective consciousness by being born

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

again in my truth. Freedom, free will, and the ability to use them is my truth. I need nothing other than my thoughts

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

to baptize me. Once aware of the power of my truth, I can share it in gratitude and love. Freedom is Love. Gratitude

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

Professional from academic institutions, pharmaceutical industries, health care indust

is love. Sharing is Love. Love is All There Is.

Just thinking about the changes that my freedom would bring to my

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

world is exciting. Using my truth will change everything I see. I no longer see useless conformity, or challenging me

.

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

hods of control, or war and deadly destruction. I see peace, abundance and joy. I feel those things and express them,

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

Companies that provide selfless information through particip

and become them.

Giving birth to myself is remembering who I am, a spirit having a human experience in love and joy

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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