Advice Pool - Self Improvement

I was frustrated, not for the first time, by a particular person. Someone who does things very differently than me--in m

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 opinion, too slowly, or without enough regard for reality. This person was unconcerned, in my mind, about what was imp

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

Examples of combination products may in

rtant, and focused only on the negative. I did not want to deal with the person or the situation, but circumstances bein

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

g what they were, I had to.

I knew it was I who probably had the wrong perspective. So I took the matter to God in pray

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

r. And this time, I think I heard a clear word in my spirit. A clear message.

I had recently been to a church retreat c

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

Combination pro

lled “The Kingdom and the Poor.” One of the most powerful moments of the retreat was when the leader had various people

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

simply read the scriptures that mentioned “the kingdom of God” and another set that mentioned “the poor.” No comments,

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

ust the scriptures, one right after another, cascading over us, word by word constructing a picture of God’s vision and

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

God’s heart.

When I went to prayer about my attitude toward this particular “difficult” person, the words that imprinte

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

on my soul were, “In my kingdom there is room for all kinds.” And the sense was that, not only is there room, but “all

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

kinds” were welcome, honored, cherished.

How different from the world, that dictates membership into The Accepted: you

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

Following aspects would a

must be successful, productive, rich, beautiful, powerful, productive, useful. The whole advertising industry, to mentio

dd to the challenges in developing combination products:

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

only one, is built upon reinforcing this. Why do people strive so hard to look as young as possible, to acquire as many

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

possessions as possible, to become as successful as possible? Not really to get or become the thing itself—beautiful, r

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

ch, or successful—but, I think anyway, to become Accepted.

God’s way is different. God says “You’re accepted” just beca

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

se he made us. I think he actually likes people who are “different” in some way, who have some sort of handicap or diffi

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

Professional from academic institutions, pharmaceutical industries, health care indust

culty. His compassion is activated by our need, and his nature is to be compassionate, kind, loving, gracious.

“In my k

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

ngdom there is room for all kinds.” The words changed my attitude toward my Difficult Person. Knowing God loves that per

.

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

son--welcomes that person without asking for any change at all--humbled me, challenged me to do the same.

It also made

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

Companies that provide selfless information through particip

e look at myself, at my own lacks and faults, and feel very, very glad that “in my kingdom, there is room for all kinds.

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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