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Negotiation. Involves two or more parties who are engaged in direct discussions with each other in a concerted effort of re

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

aching an agreement. Both parties use persuasion and influence to get the other party to see things their way.

Example:

 A

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

Examples of combination products may in

buyer and a salesman are negotiating a price for a car.

 A wife is negotiating with her husband over use of finances.

=

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

07; A president is negotiating with another country’s leader to remove missile silos that threaten the security of the nation.

Ar

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

bitration. This is a form of resolving conflict that is handled outside of court where both parties come before a neutral third-

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

Combination pro

arty. The neutral third-party is usually a lawyer and the arbitrator listens to both sides and then passes judgment on a winner and

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

a loser in much the same way as a judge does.

Example:

 Two employees are having issues with each other. They take these i

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

sues to the boss. The boss hears both sides and then decides to fire one of the employees.

 Two siblings are having a fight

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

and the mother gets involved. The mother hears what they have to say, and of course both siblings are pointing fingers at the other

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

side. The mother decides to ground them both.

Mediation. Similar to negotiation, but mediation involves the use of a neutra

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

l third-party who assists the negotiating parties in reaching an agreement. Mediation is used typically when direct negotiations hav

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

Following aspects would a

e failed because the mediator can separate the people from the problem much easier than the stakeholders can.

Example

 A b

dd to the challenges in developing combination products:

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

yer purchases a used car from a seller. The car breaks down soon after. The buyer demands his money back. The seller accuses the b

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

uyer of damaging the car himself. Instead of dealing with the matter in court, which can be both costly and time-consuming for both

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

arties, they instead agree to hire a mediator and work out their situation out of court.

 A couple decide to get a divorce,

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

but argue over who gets what. Instead of waging legal war against each other, they decide to work out their agreement with a divorc

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

Professional from academic institutions, pharmaceutical industries, health care indust

mediator. The mediator uncovers what the needs and interests are for both the husband and wife as well as separating the emotions f

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

rom the problems at hand.

 Two nations, on the verge of war after failed negotiations, agree to peace-talks. Neither side

.

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

rusts the other side, so they ask for the help of a neutral representative to act as mediator for their talks. Through the mediator,

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

Companies that provide selfless information through particip

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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