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Imagine you are about to embark on an exciting journey. As you explo

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

re unchartered territories, you will have an adventure that will lea

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

Examples of combination products may in

you to boundless treasures.

You will be required to battle the ele

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

ments and to conquer real and imaginary foes. You may make enemies,

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

ut you will also find new friends.

Then you discover you don't have

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

Combination pro

a map. There is no compass to guide you; and in the darkness even th

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

e stars remain hidden.

To help you out, you will receive small clue

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

along the way to guide you to your destination.

Some of these clue

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

will appear as challenges.

There will be times when these challeng

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

es appear to repeat themselves. You can choose to remain stuck in th

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

same old challenges or you can search for a better and newer way ou

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

Following aspects would a

.

What if you were told that you have always had a door open to yo

dd to the challenges in developing combination products:

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

u, and the map you were wishing for was one that you could write for

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

yourself.

Would you prefer to continue to struggle in the darkness,

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

or would you take the opportunity to create a map that would make th

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

e navigation easier on your journey?

There is a way to design a jou

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

Professional from academic institutions, pharmaceutical industries, health care indust

ney as unique as you are, to unlock the mysteries of your struggles,

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

and position yourself where you want to be.

You can use a systemati

.

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

c approach that you can explore anytime you choose.

All it takes is

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

Companies that provide selfless information through particip

the patience to practise what you learn and the willingness to begin

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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