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For we do not have a high priest who is unable to sympathize with our weaknesses.

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

--HEBREWS 4:15

He was the kind of fellow you’d invite to watch the Rams-Giants

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

Examples of combination products may in

ame at your house. He’d wrestle on the floor with your kids, doze on your couch,

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

nd cook steaks on your grill. He’d laugh at your jokes and tell a few of His own.

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

And when you spoke, He’d listen to you as if He had all the time in eternity.

An

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

Combination pro

one thing’s for sure, you’d invite Him back.

It is worth noting that those who

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

knew Him best remembered Him not as Jesus Christ or Lord Jesus, but as Jesus. Thi

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

k about the implications. When God chose to reveal Himself to mankind, what mediu

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

did He use? A book? No, that was secondary. A church? No. That was consequential

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

A moral code? No. To limit God’s revelation to a cold list of dos and don’ts is

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

s tragic as looking at a Colorado road map and saying that you’ve seen the Rockie

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

Following aspects would a

s.

When God chose to reveal Himself, He did so (surprise of surprises) through a

dd to the challenges in developing combination products:

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

human body. The tongue that called forth the dead was a human one. The hand that

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

ouched the leper had dirt under its nails. The feet upon which the woman wept wer

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

calloused and dusty. And his tears…oh, don’t miss the tears…came from a heart as

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

broken as yours or mine ever has been.

So people came to Him. My, how they came

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

Professional from academic institutions, pharmaceutical industries, health care indust

to Him! Why? Because He refused to be a statue in a cathedral or a priest in an e

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

evated pulpit. He chose instead to be Jesus.

SPREAD THE WORD THOUGHT FOR THE DAY

.

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

The Jesus we serve in our lighthouses is not some religious icon or set of rules

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

Companies that provide selfless information through particip

He’s Jesus, and if we show our neighbors who He really is, some will come to Him

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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