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The Power of Choice A column providing motivation to create an inspired life! By: Angie Lund – Motivational Speaker & Life Coach

Life is about

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

choice, not chance. However, many do not understand this and let life situations and reactionary emotions dictate life experience. Instead, unde

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

Examples of combination products may in

stand life happens through you, not to you. When you connect with this belief and recognize that you have the ability to choose who you are and h

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

ow to react in any given situation, you will take control of your life and create the best life possible. Be aware of this power. Embrace it.

I

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

as first introduced to this concept when I was a teenager. While visiting my friend one day, I witnessed an argument between her and her mother.

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

Combination pro

At the point of climax my friend yells, “Mom, you make me so mad”, and leaves to room with teenage flair. To that her mother responds, “I don’t m

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

ke you mad; you make yourself feel that way.”

This was profound. The light bulb went on immediately as I meditated on those words. It was a defi

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

ning moment, an epiphany for my emotional life. I immediately decided that I would no longer allow myself to succumb to my emotional tirades. Tha

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

I would take control and realize I could make the choice to let others make me angry or I could choose something else. When I was angry I would

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

take responsibility for that emotion, understanding I control my reaction. I can choose anger or I can let it go. I can choose hate or I can choo

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

e forgiveness. I can choose to let someone else dictate my life or I can create my own story.

What do you choose? Look at your life for a moment

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

Following aspects would a

and see how your choices have created your current situation. Are you holding anger and resentment about situations in your past? Understand that

dd to the challenges in developing combination products:

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

no matter what has happened, no matter how trivial or significant, you have the power to let it go and move beyond it. Holding onto anger gives

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

thers power over you. That anger dictates further choices and feeds additional resentment. It can be a challenge to escape this pattern of negati

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

vity. But, you can.

When something happens that makes you angry, feel the feelings. There is something to them. Don’t deny them, validate them.

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

ook at why the situation made you react the way you did. Try to understand the emotions. Did they do or say something that touched an insecurity?

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

Professional from academic institutions, pharmaceutical industries, health care indust

Did something happen that caused you to lose trust in someone you love? Do you feel violated in some way? Do you feel that you are not being hea

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

d? Recognize the root of the anger, deal with the emotions and then get rid of them. Release yourself from the grasp of the situation. Forgivenes

.

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

s is freeing. Focus on what you can learn and how the circumstance will make you grow. There is always a lesson to learn, even when you cannot co

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

Companies that provide selfless information through particip

ceive what that lesson could possibly be. Keep your eyes open. There was something there. You will see it eventually, if not immediately, someday

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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