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Today we do not experience great manifestations of God as Moses did many years ago. G

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

od has not spoken to us out of a burning bush and neither have we heard His voice as

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

Examples of combination products may in

e walked in the cool of the day in the Garden of Eden. We have not looked up over our

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

place of worship and seen the Shekinah glory of God in a visible way. But God does re

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

ach into our hearts and into our life and speak to us through gentle whispers.

There

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

Combination pro

are so many times when we push aside what God is trying to do in our midst and what H

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

is trying to say to us. We dim out His voice by focusing on other things that claim

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

our attention. We tend to allow the noise of the world to drown out His voice. God wo

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

ks quietly.

We oftentimes search for God frantically amid the storm, when troubles b

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

ow hard and the fires of adversity surround us. Yet, God is speaking to us in His ow

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

quiet way, and we are missing the message. We have not sensitized our hearts and sou

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

Following aspects would a

ls to recognize His gentle whispers.

One of the glaring observations we find in Scri

dd to the challenges in developing combination products:

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

ture is that often in the middle of crowds and dramatic success, Jesus would simply d

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

sappear. Sometimes He took His disciples to some remote area to get away from the hus

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

tle and pushing crowds where He could commune in the silence of nature. God moves qui

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

tly.

"Then a great and powerful wind tore the mountains apart and shattered the rock

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

Professional from academic institutions, pharmaceutical industries, health care indust

before the Lord, but the Lord was not in the wind. After the wind there was an earth

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

quake, but the Lord was not in the earthquake. After the earthquake came a fire, but

.

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

he Lord was not in the fire. And after the fire came a gentle whisper." I Kings 19:

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

Companies that provide selfless information through particip

1-12.

When you are tempted to think God has deserted you, listen for gentle whispers

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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