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An interesting but profound observation is that the sun always rises.

Rega

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

rdless of our circumstances, and in spite of where we are or want to be, th

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

Examples of combination products may in

e Sun still rises each and every day. Perhaps we should learn something, h

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

ere. Maybe we are due for a major paradigm shift in our lives.

Did you se

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

e the Sun rise this morning? Regardless of location, position, lot or stat

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

Combination pro

ion in life we are all given a sunrise every morning. But so many of us do

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

not take the time to observe the beauty in this gift.

We do not see the l

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

ife refreshing rays as they peek softly over the horizon gradually flooding

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

the landscape with new energy and hope.

This infusion of power brings all

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

nature back to life, everything in it’s proper order and purpose moving fo

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

rward to enjoy the new day.

And so it is with us.

The Sun rises upon us e

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

Following aspects would a

very morning. It renews our opportunities of energy and hope. It provides

dd to the challenges in developing combination products:

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

us with another period of time to move forward to accomplish our duties an

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

d plan for our futures.

And, unlike Nature, it is particularly symbolic to

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

each of us as human beings in that we have a new day to correct and improv

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 ourselves, as well.

We can perform that needed service. We can recommit

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

Professional from academic institutions, pharmaceutical industries, health care indust

ourselves to our goals. We can seek forgiveness of those we have wronged

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

and pledge our minds and hearts to become better people.

There is always a

.

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

sunrise. A refreshing of Nature. An opportunity to change and make our l

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

Companies that provide selfless information through particip

ives better.

We only need to take hold of the gift, and use it more wisely

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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