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When negotiating in a crisis situation time is always a major considerat

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. Time can be your best friend and how you use it will determine your

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

Examples of combination products may in

outcome many times. Ask any hostage negotiator about time, it is always

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

he key. The key to Negotiating in a Crisis Situation is time; The Time F

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

ctor must be considered.

Juries often swing from one side to the other

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

Combination pro

ue to time factors, other responsibilities, family issues, it is often a

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

much about time as it is about the actual circumstances. It is amazing

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

ow time affects the human brain and those caught up in a larger game.

S

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

metimes time will allow things to mend themselves and often the problems

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

will go away. Sometimes there is no time left, no more time out and the

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

all is in play and negotiation time is well, out the window, so watch it

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

Following aspects would a

fly.

Take the current situation with the Iranian enrichment of Chinese

dd to the challenges in developing combination products:

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

Uranium stock to make Atomic Bombs or nuclear tipped warheads to shoot i

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

to Israel or to Blow Israel off the Map, as stated by the Iranian Presid

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

nt? Well time is of the essence and therefore we are now Negotiating in

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

Crisis Situation. Why you ask? It is all about; The Time Factor.

When

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

Professional from academic institutions, pharmaceutical industries, health care indust

egotiating use time wisely, watch the clock, use time as gift or a hatch

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

t. Show the other party you are serious thru action and never lie to tim

.

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

, because it is a free flowing tool and once it is spent your negotiatio

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

Companies that provide selfless information through particip

could reach an impasse and then all bets are off. Consider this in 2006

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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