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“Cast all your anxiety on Him for He cares for you.” 1 Peter 5:7.

I don’t know if you have ever

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

been fly-fishing or maybe you have seen it on TV. When you go fly fishing you cast your bait wa

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

Examples of combination products may in

y down the river and let it float. That way the fish does not see you and hopefully attacks the

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

bait. I have that vision when we cast our anxiety on God. Do you give Him your anxieties and let

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

them float away and realize He is in control or do you keep the bait close so you can pick up t

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

Combination pro

e anxiety whenever you want? If a fly fisherman keeps his bait close he will scare away the fish

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

. If he allows the bait to float downstream he is more likely to catch a fish.

I think when we

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

keep our anxieties close God is unable to work and we are unable to even look down stream. Also,

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

when we keep our anxieties close we focus on the anxiety and take our eyes off of God. When we g

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

ive our anxieties to God and leave them there He is more able to work and we are better able to

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

est. I must confess I am good at giving God my burdens and worries, but I quickly take them bac

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

Following aspects would a

k. Why wait on God, maybe I can figure this out myself? Do I really trust God to take my worrie

dd to the challenges in developing combination products:

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

s and take care of them? When I look closely at the above verse I often focus on the first part,

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

cast all your anxiety on Him. The second part is almost as important if not more important. Beca

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

use, my God cares for me, He wants to carry my burdens and He wants me to bring them to Him. He

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

cares about all my burdens, not just some of them. He loves and wants me to share my worries and

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

Professional from academic institutions, pharmaceutical industries, health care indust

concerns. God certainly knows what is best for me and only wants the best.

So, I ask you “Wher

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

e do you cast?” Once you cast your anxiety, do you leave it with God or do you take it back? God

.

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

cares for you and cares about absolutely everything you care about. He made you and He loves you

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

Companies that provide selfless information through particip

. Give your loving Father all your anxiety and leave it there. May you rest in His perfect peace

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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