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Here is an oft-heard complaint, “I have all the responsibility, but none o

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

f the authority.” Those in middle management most often say it. The fact

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

Examples of combination products may in

is most people who manage are in the middle. Very few people have no one t

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

o report to, even if it is only their banker. Nevertheless, it points to

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

this valuable and misunderstood concept.

Responsibility carries within it

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

Combination pro

self the authority necessary to accomplish the task.

Did you say, I autom

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

atically have the authority to do that for which I am responsible? Yes --

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

that is exactly what I said. If you have accepted responsibility, you have

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

a right to assume the authority necessary to fulfill your responsibility.

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

In reality, our complaining that we do not have the authority, is a veile

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

d refusal to accept the responsibility.

Now, let’s take this concept out

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

Following aspects would a

of the workplace and apply it to our very own personal life. We each hav

dd to the challenges in developing combination products:

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

e the authority to run our own life. We have the authority to choose the

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

who, what, why, where, and how of our life. It is totally 100% up to us.

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

obody has authority over my life, but me. Nobody has authority over your l

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

ife, but you. We may abdicate, delegate or surrender control, but when we

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

Professional from academic institutions, pharmaceutical industries, health care indust

do so, the choice is ours.

So here are two statements, both are equally t

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

rue.

We each have all the authority necessary to do all for which we are

.

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

responsible.

We each are responsible for all we do because we have all th

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

Companies that provide selfless information through particip

e authority.

There is no one to blame. How cool is that?

It’s your move

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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