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What we name something matters.

It sets a tone that alters our attitude.

Give someth

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

ing a new name and the difference may seem insignificant or even trivial.

However, if

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

Examples of combination products may in

it changes our attitude, it can amount to a very big change.

Recently, I heard the te

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

m “survival job.”

I understood this to mean a job that is often part-time and unrelat

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

d to one’s primary career focus. One takes such a job because one’s previous position

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

Combination pro

as been eliminated, out-sourced, down-sized, off-shored, or otherwise zapped.

I heard

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

this term a few times and thought, “Why does the phrase ‘hunker-down’ come to mind?”

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

The term suggests an image of bunkers, flack jackets, helmets, and a sound track of vo

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

ces shouting “incoming!”

That doesn’t exactly give a warm, fuzzy feeling, does it?

M

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

ybe we can’t change the immediate reality of making ends meet as rapidly as we might w

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

sh, but we can change our attitude by some imaginative and empowering nomenclature.

S

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

Following aspects would a

uppose a “survival job” becomes a “stepping stone job?”

What difference would that ma

dd to the challenges in developing combination products:

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

e?

Well, the whole notion of heaving a sigh of relief at getting through another day

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

ith body and soul in one piece changes.

Our focus is on where we are going and what w

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

are learning in the process rather than braving another day in the wilderness.

After

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

all, if are in this temporary situation anyway, why not make it a transition to someth

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing better?

Why make it sound like a reality TV show where the whole world is on the

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

erge of voting us off the island and into a shark-infested bay?

It may be a small cha

.

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

ge, but it alters the internal landscape and engages the mind in a powerful way becaus

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

Companies that provide selfless information through particip

it changes attitude.

And with a new attitude, we will do lots more than just survive

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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