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Have you ever played on a serious sports team or worked in a management posit

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

ion? Have you ever been on a committee where everyone had to pull their weigh

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

Examples of combination products may in

t to pull off a rather large project to insure success? Have you ever noticed

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

that there invariably in the group was a weak link and it just really made t

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

hings tough on the rest of team?

You probably thought to yourself how unfair

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

Combination pro

this was. Perhaps you had a talk with them, tried to motivate them or worked

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

to move things forward? Then each time you mentioned a point of contention y

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

our found that their excuses just kept coming faster and faster at you and yo

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

u thought to yourself if they had this much time to think up all these excuse

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

s then they certainly have enough time to do their share of the work, assignm

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

nt or duties to complete the task, target or mission.

Simple stuff really, b

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

Following aspects would a

ut how do you deal with an excuse maker of this caliber? Well some teams who

dd to the challenges in developing combination products:

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

are really into winning and not so much political correctness will simply thr

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

ow them off the boat, or island and say; You’re Fired!

And rightfully so, no

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

w many of you are probably thinking that I am a hardliner and don’t understan

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

d and that I should have more compassion, put my self in their perspective an

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

Professional from academic institutions, pharmaceutical industries, health care indust

d have more empathy towards these losers in life?

Indeed, I know what you ar

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

e thinking and if you really believe that; well thank god you are not on my t

.

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

eam or we’d throw your rear end to the sharks. No losers on this boat. Think

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

Companies that provide selfless information through particip

on this in 2006 and stop being a loser you make yourself look stupid and weak

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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