Advice Pool - Self Improvement

In one’s life, there are those very special moments that may appear trivial to some, but could be a vision of priceless values to others. Moments that is a creatio

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

n through a certain object, time, or atmosphere. At a recent annual family gathering, I received a very special priceless moment from a simple but heart-touching c

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

Examples of combination products may in

eation.

We received on this day the gift of a perfect autumn afternoon. The annual reunion of family gathered under the park shelter, each acknowledging how the b

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

eautiful fall colors and the serenity of the surroundings added to the laughter and friendship of family. The whispering aroma of the barbecue brought the sense of

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

flavor for this joyous occasion.

As we gathered in a family circle to give thanks for blessings received, my uncle began to share the words of being grateful for

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

Combination pro

all that we were given. My uncle then paused for just a moment, and acknowledged family members who were with us in spirit. It has been several years since a loved

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

one in our family has moved on, but they are the true reason why the gathering under a park shelter on this autumn afternoon was together as family.

The lines beg

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

in forming to fill plates with a delicious bounty, but my thoughts were not immediately moved toward the tables filled with homemade delicacies. What captured my a

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

tention was the spiritual energy of my grandmother near a table adorned with something other than our family meal. She was smiling with pride as if to relay she fe

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

lt very lucky to be remembered so. I did not understand why she was standing near this particular table, but always know my grandparents would never miss a family

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

athering. As I moved toward the line, I glanced over once again to see if my grandmother was still smiling. Her presence was no longer visible, but I felt her smil

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

Following aspects would a

e even more. Later I found the reason why.

Earlier arriving at the park shelter, it was a request that I walk over to a certain table and write down an estimated

dd to the challenges in developing combination products:

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

uess of the number of small bands encased within a large glass jar. This was no surprise, as each of our family reunions include a bit of creativity. I stood at th

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

e table and looked at the jar filled with the small colored bands and silently stated that the task would be nothing but a complete guess. Suddenly I heard the wor

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

s “you’re the oldest, write down what you hear.” Again I was in complete confusion, but wrote down the number ‘208’.

My aunt announced that the correct number of

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

bands in the glass jar was 212, and that I was the closest with 208. What she placed in my hands was a special moment – for the gift was a hand-made quilt made fro

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

Professional from academic institutions, pharmaceutical industries, health care indust

some of my grandmother’s dresses she wore.

Looking down at the quilt, I then knew why I had saw my grandmother standing near that table with a beautiful smile. I

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

t was the same table the quilt was carefully placed as part of this family gathering. As my fingers carefully touched the fabric of grandmother’s dresses, I knew t

.

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

is was one of those special moments in my life’s plan. I am my grandparent’s first grandchild, and grandmother brought to my life memories of love and devotion to

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

Companies that provide selfless information through particip

family. To some it may appear as a simple quilt, quite possibly even a bit trivial. For me, this object, time, and atmosphere will always be - a priceless moment

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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Advice Pool - The Quilt: What May Be Fabric To One May Be A Special Memory To Another

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