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Summary - Choices: Negative Consequences or Positive Results of Our Ethical Choices
Over ten years ago I learned a profound lesson: You reap what you sow. While many people feel that they can avoid consequences - one thing is for sure – consequences are inevitable. Every choice we make will ultimately y
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
ield a result. In my case, unethical choices resulted in a prison sentence. The following is an excerpt from my journal. As I look back I now know that we have more control over our destiny than many think. Our choices
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
can, in fact, yield negative consequences (prison as an example) or positive results (professional speaker and business executive today).
Perhaps the excerpt from my memoir may benefit others as they seek to recover from
Perhaps the excerpt from my memoir may benefit others as they seek to recover from
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
choices they made – after all we do control prospective positive results since they are all found in the seeds we sow.
October 8, 1995.
Seems like each day is riddled with some emotion. At times, it seems the sadness c
October 8, 1995.
Seems like each day is riddled with some emotion. At times, it seems the sadness c
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
omes in waves and is more than I can hold back. I feel much compassion, for some of these folks here. There seems to be two types of inmates here – those who will always be in trouble, and those who will grow from the ex
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
perience and never be back.
This afternoon I went walking on a gravel track. I remember before arriving here, people calling this, “Club Fed." One thing I can assure them, it is no country club! As I was walking, howev
This afternoon I went walking on a gravel track. I remember before arriving here, people calling this, “Club Fed." One thing I can assure them, it is no country club! As I was walking, howev
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
er, I heard Elton John's, “The last song." Seems like every time I turn around, I am bombarded with emotion. A line in the song says, “I never thought I'd lose, I only thought I'd win." That's the way I felt. Then the
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
thought came to me -- maybe by losing -- I win.
I wrote a letter this morning to the members of my former Sunday school class. It reads as follows:
Greetings from prison,
Today is my first Sunday here, and I thought of
I wrote a letter this morning to the members of my former Sunday school class. It reads as follows:
Greetings from prison,
Today is my first Sunday here, and I thought of
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
you. It's 9:45 a.m. and you are just now getting together.
Prison is not bad -- but then I wouldn't recommend anyone join me. The warden's comments are, “You are here as punishment, not for punishment. This philosophy
Prison is not bad -- but then I wouldn't recommend anyone join me. The warden's comments are, “You are here as punishment, not for punishment. This philosophy
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
means that you are being held in prison, away from your family, your community, and not being allowed to leave without authorization.” The people here are, for the most part respectful.
I seem to be dealing with being h
I seem to be dealing with being h
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ere O.K., however, the pain I feel in being denied being with my children is tough. A parent's bond with their children is strong. Being away a week is not critical, but thinking of missing Christmas is tough. The time,
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
I must spend away seems like an eternity to me. Hopefully, it will pass fast.
I joined the choir here. I always wanted to sing in a black choir -- so here I am. Reminds me of “Forrest Gump" in the church choir he san
I joined the choir here. I always wanted to sing in a black choir -- so here I am. Reminds me of “Forrest Gump" in the church choir he san
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
g in – swaying, hand clapping and all.
I attended church service this morning. There are some beautiful spirits here - I must say and I look at people differently now. I'm much less judgmental. What I did was wrong and
I attended church service this morning. There are some beautiful spirits here - I must say and I look at people differently now. I'm much less judgmental. What I did was wrong and
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
you reap what you sow. I am now reaping. Yet, while people can make mistakes or get caught up in wrong things -- that doesn't take away the fact that they are still God's children. Worthy of forgiveness. I hope I neve
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
r looked at the poor, the afflicted, the old, or deprived the same way I used to look at them in the past. As you stand here on a visiting day and observe a group of men waving to their families as they leave after a visi
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
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 and see tears well up in their eyes -- you feel compassion and love.
Be thankful each day for what you have. Freedom is precious. Hug your children and tell them you love them -- they are truly a gift from God. Share
Be thankful each day for what you have. Freedom is precious. Hug your children and tell them you love them -- they are truly a gift from God. Share
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
with your husband or wife your love. It's funny how the little things in life are important -- having a home, your own clothing, food of your choice -- all these seem to be taken for granted.
I am thankful for you as my
I am thankful for you as my
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
friends. Keep me in your prayers, along with my family. I will keep you in mine. I hope someday I'll be able to share this experience through speaking to others. How important it is to appreciate what we have. Most i
.
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
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
mportant is our relationship to each other. Money, cars, houses will all pass away -- we may not have the opportunity to show our love again.
Through this letter, I want to let you know, my love for you!
God bless you,
Through this letter, I want to let you know, my love for you!
God bless you,
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
Chuck
Looking back, my experiences placed me on the right track. As I journaled my experiences, I find that my efforts today to share with others, a message of hope and inspiration, was well founded and the path is clear
Looking back, my experiences placed me on the right track. As I journaled my experiences, I find that my efforts today to share with others, a message of hope and inspiration, was well founded and the path is clear
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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