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The Merriam Webster Collegiate dictionary defines Responsibility as follows:

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

he quality or state of being responsible: as a) moral, legal, or metal accountability.

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

Examples of combination products may in

) Reliability, Trustworthiness;

Something for which one is responsible; and

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

Taking control and charge over your life.

Responsibility is a task that

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

requires a solution. Taking responsibility means, making oneself accountable to the sol

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

Combination pro

tion for a particular problem. Taking responsibility for our actions, failures and maki

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

g oneself accountable, is an important step in moving beyond mediocrity status quo and

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

achieving extraordinary results. Most people (Mp), blame everybody except themselves. T

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

ey refuse to take responsibility for their inadequacies but are willing to blame their

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

ducation or lack of it, qualifications, their employer, the economy, the government, th

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

ir families and the neighborhood they grew up in. Well, one of the outstanding traits o

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

Following aspects would a

successful people is that they accept responsibility for themselves and refuse to blam

dd to the challenges in developing combination products:

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

others for their condition in life. With that said, the most important personal decisi

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

n you can make, is to accept complete and unequivocal responsibility for everything you

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

are and everything you will ever be. Everything remains in its state of rest or motion

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

until an external force is applied to change its course. Your life will remain in a sta

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

Professional from academic institutions, pharmaceutical industries, health care indust

e of rest or gravitate toward the same direction that is not your choice, until you dec

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

de to take responsibility to change its course. Today, our lives and environment yearn

.

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

or transformation, earnest manifestation, even so the major force required to bring a c

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

Companies that provide selfless information through particip

ange in the existing circumstances lies in taking responsibility for the desired change

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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