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  • Delicious - It's Ok To Be Human

    One of the things I have had to deal with since I was old enough to know the difference between good and bad was that it IS NOT OK to be human.

    I was raised in a generation of going to church on Sundays. Most all businesses were closed on Sunday and at least one other day of the week. Sunday was the day that all of us sinners could go someplace and feel good about ourselves for at least part of a da
    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
    y. Most of all, I felt that it was a day that my only parent, my mother could get rid of us for a few hours of peace. We lived in a rural area, and within this area we moved many times. We were shuffled off to Church each Sunday either by a neighbour or on a bus if the church happened to provide one. My Christian background included many different theologies depending on transportation to the church
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    hat Sunday.

    I believe that the one thing that most stood out from years of this kind of exposure was that it was NOT OK to be human. It was something that we had to tolerate being because we had not choice and no matter what we did, we could not do it right or win favor with the All Mighty. We were in a constant state of repentance. The human thing to do was to try not to be human and wait for the d
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ay that God would take us away and make something worthwhile of us. In my child's mind being human was not the most desirable aspect of life. I could not see anything that I could do to make my lot better other than to go to church and confess that I was bad and needed atonement.

    Even in my immature mind I could not see the reasoning behind God creating something as imperfect as humans, except for G
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    d's own vanity and self gratification. What a worthless God and what could be wrong with him I thought that he would need us to make him feel better? The whole experience left me with a knowing that something was wrong with what I was being asked to accept, it was pure nonsense.

    I left the church in my late teens and never went back. It boggles my mind even today that some very intelligent people st
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ll hold onto those beliefs out of fear. I truly understand what it means to be God fearing for these people; surely intelligence does not enter into it. The need to believe in something is so strong, is so overpowering that many are willing to believe in a system that points a finger of damnation at us and obviously does not bring us the things that we desire most in our physical lives. Why would we
    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
    leave a place of security before birth to come to this physical place only to exist for the moment when we can go back? I cannot believe that we are here to be humble and powerless. As humans we don't naturally live that way. We don't exist at home as children trembling at the feet of our parents to be something less than they are.

    By nature we strive to be independent of our parents and better than
    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
    they are. Most good parents try to instill these values into their children and guide them to independency and I have observed that it is their wish that their children become much better off.

    Years later and a lifetime of listening to this religious dogma I still do not believe that being human is a bad thing, that we are so lost and evil. Even in our darkest hours I believe that we are perfect the
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    way we are. I believe that the concept of good and bad has not worked for us over the centuries and it is observable that it has not given us the promise of peace on earth, abundance, joy and good will to all mankind.

    Humanity is evolving, life evolves and it is OK, is natural and appropriate that we are the way we are in this moment. As we mature are thoughts change and we change and we will find
    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
    urselves in another area of understanding that works for us. In fact the whole idea of good and bad, right and wrong needs to disappear from our minds. These concepts rob us of our power and they simply do not work any longer.

    New concepts of what works and does not work for us need to replace these words. If we simply acknowledge that something in our life is not working instead of "it is bad", or
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    it is wrong," this new concept will take away the negative, destructive feelings of being blacklisted by a vengeful God. Likewise if we simply acknowledge that something is working for us, we will also drop the thoughts that we need to be rewarded for being good. In other words we will take full responsibility for all things that happen in our lives without thought of approval or of being good or bad
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    . We will loose the feeling of being subordinate and subservient to God. It makes good sense to believe in a God that has given us power to demonstrate our lives in a safe environment with total freedom to be human in whatever manor we choose and freedom to express ourselves fully without limitation and approval. To be God is to be human and visa versa because God is all there is. We can be no less o
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    more than that which we already are.

    Being human is doing whatever is natural for humans to do. Punishment and reward are human concepts used to control the natural expression and curiosity of humanity so that it fits into the excepted norms of the community. Also for the purposes of the Church if one can be made to feel less than you are, it means supporting the Church and winning favour by contri
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    buting. So it is not in the best interest of any organization to have its members leave, and the best possible way to have them stay as observed over centuries of Church domination of spiritual matters is to hold the power of fear over them-it is observable that it works.

    We do not ever have to apologize to God or anyone else for being human. We do not have to ask this God forgiveness for stealing,
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    illing, or plundering and we do not need to be blessed or rewarded for living a life that is progressive; it is the natural thing to do. What we have to do is learn to take personal responsibility for our actions and notice that some things do not work for us in achieving a higher position on the evolutionary chain.

    We need to singularly get to a point of awareness of understanding that it works in
    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
    ur own best interest to become progressive and tolerant, to bring our awareness to a level that we will only do those things that are life affirming, and which takes us to the next higher level of acceptance and understanding. To be human is to experience all aspects of physical life and to move forward. That is exactly what we are doing now and always have been doing. It does not serve anyone to hav
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    e any individual made to feel inferior or less human because of his actions. In any enlightened society, it works for the benefit of all to educate and guide all persons through concepts of love, joy, abundance, and acceptance and away from fear. Fear is the opposite end of the stick with unconditional love at the other end.

    For the thousands of years that humanity has walked this earth, this is the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    one concept that it has been unable to grasp, "fear does not work," in moving towards enlightenment. Being human is only one stage in our process of evolution. Because we have absolute freedom of choice to create our own physical reality, why would we choose to continue doing things that do not work for us, considering that it is peace, joy and abundance that we are all looking to experience?

    I don'
    .

    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 believe that it works in our best interest to use the excuse that "I'm only human," to justify not moving forward. Humanity can be anything that it decides to be, why endlessly experience the dark side when we can move through the light of what man is most capable of, physical love, compassion and joy.

    It really is OK to be human if we begin to believe that we are truly worthy and need not bow or
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    pologize to any God, if we understand that we really are God in human form simply experiencing physical life through our bodies. If we understand that God is a life-force not a person that looks over us, that punishes or rewards us. God is life, we are life, we are God experiencing self through all the probabilities of existence. God does not have to apologize for expressing him/herself in human form


    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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