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Do you ever wonder why people do not simply do the things that you want them to do? Well, instead of waiting for things to happen, decide to take responsibility for making them happen. The way to do this is often as simple as making an appropriate request.

Requ

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

ests are the engine that drives action. To the extent that you become proficient in making requests that people understand to be in their best interests, they will comply with your wishes and honor your requests. To the extent that your requests come across as

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

Examples of combination products may in

self-serving and in only your own best interests, you will likely meet with opposition and avoidance. The best way to access your power through impacting others is by making requests that move people into action. By moving the action forward, you are able to take

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

an insight you have into what would support you, someone or some situation and make a request that has the person move into accomplishing something they may not have in the absence of your request. In our culture, people generally operate out of the mistaken no

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

ion that information is the source for action. Information alone produces no results without the ability to act upon the knowledge you have and move the situation forward. Making a request is a conversation that does just that and produces action. So, if requests

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

Combination pro

cause us to move people and situations powerfully forward, why don't we typically make them routinely to bring about a result? The answer lies in the following areas.

1-We are often fearful of having our requests declined. With the mere possibility of getti

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

ng turned down, we will retreat and hide under a rock. A good example to demonstrate this is asking someone out for a date. You might really want to date that special person but that little voice on your shoulder reminding you that they just might turn you down c

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

n cause paralysis. If you are more committed to getting the date than you are to protecting yourself from potential rejection, you'll pop the question. If the reverse is true, you might never know if the answer would have been ...YES!

2-We are more committed to

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

looking good (or not looking bad) than to making a difference by making a powerful request. Again, when your focus is on yourself, you trade your ability to impact others for protection and comfort. Look to contribute to someone else instead or focus on somethi

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

ng worthwhile, something larger than yourself or your all-too-often petty concerns and you will not be so concerned about how you are looking!

3-We are not clear about what requests to make and what needs to happen in a particular situation in order to bring abo

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

t a result. Our lack of clarity results in paralysis.

4-We are not skilled at making requests in such a way that they can be heard and acted upon by others. When the requests we make are not seen by others to be in their best interests, they may fall on deaf ear

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

Following aspects would a

s.

One way to get our requests heard and acted upon is to combine our request with a promise. I request that you do (whatever) and if you do, I promise to do (this)...in return. Having the requests you make be accepted and acted upon will be a function of how ef

dd to the challenges in developing combination products:

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

fective you are in creating a listening for what you have to say. Another way to create a listening for your requests to be heard is by speaking your commitment to the person or situation so that the reason for making the request can be understood and appreciate

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

d. Example- Out of my commitment to support you to be as powerful as you can be, I request that you practice making at least three requests every day whenever you see an opportunity to influence a situation.

To make your requests more effective, make sure that y

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

u are clear as to what must be done to satisfy the request and the time period by when your request is to be carried out. Example- I request that you hire a personal development coach by the first day of next month.

Always remember that whenever a request is ma

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

de, the person to whom it is made has four options: 1- to accept the request, 2- to decline the request, 3- to commit to respond to the request by either accepting it or declining it by some later date or 4- to counteroffer the request with a possibility that

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

Professional from academic institutions, pharmaceutical industries, health care indust

works better for you.

When, on the receiving end of a request, you find yourself needing to decline a request that has been made of you, it is important to leave the person making the request whole. And, when possible, look to see if there is a counter offer yo

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

can make to the benefit of all involved. Your ability to first recognize what may be missing in a given situation to bring about an intended result and then powerfully make the appropriate request will result in the world becoming a more obliging place that re

.

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

sponds to satisfy all your needs.

Exercise For Making Powerful Requests

Look for at least three opportunities every day in which you can make a request to move the action forward in order to accelerate your business growth. Make your requests powerfully by crea

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

Companies that provide selfless information through particip

ting a listening for them to be heard. Always include a "by when" with each request you make. Practice making requests with your prospects, your upline and downline and with your family and friends in some area that will move your business in the right direction

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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