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I spend a good deal of time writing and speaking about the importance of our relationship with God. Two-way communication—as part of an active prayer

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

life—is a key part of that relationship. There’s really no other way to grow and nurture the relationship than talking to and hearing from God. So w

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

Examples of combination products may in

at do we do when God stops speaking to us?

No one seems immune. I’m not aware of any Christian who hasn’t experienced that silence. Sometimes it’s d

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

escribed as dryness, like a drought or a desert. It’s also been called the “dark night of the soul.” Experiencing the silence of God is part of being

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

a Christian. There’s no getting around it. But there are things we can do to help us get through it.

The first step is to take a look

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

Combination pro

at potential causes for blockage. Continuing sin or an unrepentant attitude can cause a hardening of our heart. God doesn’t necessarily stop speaking

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

we lose the ability to hear Him. It’s as if we plugged our ears.

Another common blockage can be our own expectations. Perhaps we are listening for

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

only the answer we want, not hearing what God is actually telling us. We may be expecting an answer to a specific request for help; His silence could

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

be an answer that means He wants us to work, at least for a while, drawing upon our own resources. Perhaps as a way to strengthen us for the future.

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

So there are times we are not experiencing blockage—God is truly being silent, for His reasons.

Whatever the cause, His silences are uncomfortable.

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

hey may even cause us to question our relationship with Him, His trustworthiness, even what we believe about Him.

Throwing our hands up in the air a

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

Following aspects would a

d walking away from the relationship isn’t the answer. In fact, it’s not even an option; where would you go to get away from God? Getting angry at Hi

dd to the challenges in developing combination products:

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

m is understandable but no more helpful than getting angry with another person over a similar breakdown in communication. Anger brings its own form o

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

blockage.

Instead, we need to look deeper into the silence. Be willing to fully experience the silence. To relax in the silence. God could be helpi

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

ng us to detach from a dependence on results or a dependence on a particular kind of experience of Him. This is especially true if we’ve been enjoyin

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

“breakthrough” moments. He may want to move us toward more faith in Him and Him alone. We could also be learning some humility and patience from His

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

Professional from academic institutions, pharmaceutical industries, health care indust

silence, two lessons I can’t seem to get enough of.

The important thing is to persevere. (Another lesson for us, perhaps?) We must continue to than

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

God, to praise Him, to talk to Him. We must have the belief, the faith, the trust that He will resume speaking to us when it will accomplish the gre

.

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

atest good for us through His will.

Because just as we’ve all experienced His silence, so, too, we’ve experienced the re-establishment of His commun

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

Companies that provide selfless information through particip

cation. The reason behind the silence usually becomes clear, although not always right away. And invariably, ultimately, His silence is golden…for us

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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