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“For I know the plans I have for you,” declares the Lord, “plans to prosper you and no

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

t to harm you, plans to give you hope and a future.” -Jeremiah 29:11

I recently pre

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

Examples of combination products may in

ented my “Are You Ready to Start Living Your Dreams?” workshop for a group of women. At th

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

end of the session, a workshop participant came up to speak with me. She shared that God

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

ad placed it on her heart to start a ministry for single moms but she just couldn’t move f

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

Combination pro

rward.

I listened for a few minutes as she laid out her vision for her ministry – its nam

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

, mission, where it would be located and other strategic matters. Once she finished speaki

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

g, I had just one question for her, “What are you really afraid of?” It was clear from our

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

conversation that this young woman had prayed and God had answered her prayers, yet she wa

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

stuck.

It’s not uncommon that as you identify your purpose and want to move forward in f

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

lfilling your destiny, doubt shows up in the form of fear. It can be the fear of failure,

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

Following aspects would a

uccess, self-doubt or something else. Whatever form it comes in, fear can have you second-

dd to the challenges in developing combination products:

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

uessing yourself – “Did I really hear from God?”

If God has given you a dream and you wan

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

to accomplish it, remember His promise in Jeremiah 29:11. He would not place a dream, mis

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

ion or purpose in your heart, if He was not going to equip you to carry it out. Part of Go

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

’s equipping is to help you through any fear that may be holding you back from moving forw

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

Professional from academic institutions, pharmaceutical industries, health care indust

rd and your ultimate success.

You are God’s beloved, His chosen one. If you depend on Him

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

to help you reach your dreams, He is able to take away all fear.

Action Challenge for You

.

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

– Answer the question: “What am I really afraid of that’s stopping me from moving forward

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

Companies that provide selfless information through particip

n God’s plans for my life? Next, decide what you’re going to do about it. Then take action

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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