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Most good negotiators will suggest that you find common ground with the other party. This maybe a wise tactic and gene

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

rally can work well. Yet, if you find this tactic being used on you, you might wish to have a strategy to make it very

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

Examples of combination products may in

tough for the other person to find common ground.

The best method I have found was to ask the other party; “you seem

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

to be trying to find common ground so that we can move forward in our negotiations, is that true?” If they say no, the

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

will generally touch their face, as itches occur when one it lying. If they touch their face tell them; “I am a very

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

Combination pro

good body language reader and you have just told me a lie, I find it hard to negotiate with someone I do not trust” th

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

n touch your face like they did in an exaggerated way. If they say; “Yes, we would like to find common ground” then im

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

mediately go into what I call my Common Ground Speech. It is an old lawyer trick, which will really aggravate you if y

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

u hear it. It is the definitional rhetoric game and it goes something like this.

Why are you so intent on having comm

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

on ground when we are talking about this other issue? Why not define what “ground” is first so we can move ahead in an

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

expeditious way. Is ground rocks, dirt, crust, volcanic ash? What about when such things are suspended in water, a sup

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

Following aspects would a

erplume or air? Is a meteorite ground? It is once it hits? Is the moon ground? It is once you are there? Is an asteroi

dd to the challenges in developing combination products:

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

ground, could be, at what size is ground? You see the problem with this inane line of reasoning, going around definin

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

g everything? Then you never get anything done, but find common ground, what about common air? Are we going to sit her

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

all night and talk about definitions? Or are we going to solve this problem? After all once you all agree on the whol

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

e of everything and all the definitions, then, well, your life experience is over and you accomplished squat. And dear

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

Professional from academic institutions, pharmaceutical industries, health care indust

sir, indeed, I had assumed that we were here to find a solution to this serious issue which is best for all concerned

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

and especially overly beneficial to me.

This wastes lots of time, wares down their patience and throws them off balan

.

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

e. Some would say this is wrong, but I would argue that when someone is lying to you in a negotiation, it serves them

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

Companies that provide selfless information through particip

right. Negotiation is not tough really, it is a matter of recognizing a liar or lawyer when you see one. Think on that

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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