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Advice Pool - An Act of God?
At 3:30 am we awoke to the smell of smoke. The hills behind our house were on fire. The flames were not yet upon us but with each gu
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
st of wind, we could see flames traveling our way. The news report made it clear, our life was in danger and our house and all of its
; 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
possessions could easily and quickly go up in smoke. The plans for the day, had seemed important, but now meant nothing. We set out
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
to prepare ourselves for the worst. We rushed through the house grabbing the things most important to us, medicines, telephone number
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s, insurance policies, etc. The first thing I threw in my car was my scriptures.
Once the car was loaded, we spent our time, frantic
Once the car was loaded, we spent our time, frantic
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ally watching the fire, listening to news reports and checking with the fire department. We were assured that if we had to leave, the
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
y would warn us. For the next two days we were on survival watch. Our possessions and vain ambitions had no meaning.
Then something
Then something
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
wonderful happened. The calls began to come. Calls from family and friends, concerned for our welfare. Calls from those we haven’t he
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ard from for a long time. There were calls from business acquaintances, offering their help. So much love was sent our way that it br
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
ought me to my senses. I realized I was so caught up in my own fear that I had forgotten about others. I had gone inward to my surviv
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
al mode and become selfish. I wasn’t thinking of others.
I made two big pots of soup and baked two cakes and began sharing with othe
I made two big pots of soup and baked two cakes and began sharing with othe
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
rs. I took it to an older couple with poor health and to friends who were also afraid. I invited my neighbors for dinner. For two da
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
ys we enjoyed having each other’s company, as we watched the flames head our way. How comforting it was to have them with us and to s
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
hare our concern.
As I thought of our situation, I realized how life had changed in one day. We, like everyone else, had been caught
As I thought of our situation, I realized how life had changed in one day. We, like everyone else, had been caught
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
up in getting ahead, making a living and accumulating things. All of a sudden we were caring about the important things of life, our
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
families, each other, helping others, and being grateful for what we had. At that time my prayers became very meaningful.
They said
They said
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
these fires were an Act of God and I began if that was true. I’m sure God didn’t start the fires to cause us pain but because of the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
fires, we were all more human, more humble, for caring. For the time, we realized what was really important.
Thankfully our home an
Thankfully our home an
.
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
d possessions were saved as the big bombers dropped water on the blaze. As I thankfully put my possessions back in their proper place
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
, I hoped I would never forget the things I learned from the Fire Storm experience and I knew the fires really had been an Act of God
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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