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FEAR! To what extent does fear rule your life? How is fear controlling or motivating you? Bring up the topic and watch people react. Our lives incorporate so many beliefs about fear- reinforced by what we tell ourselves and what we hear from others. Is it an

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

y wonder that finding peace and serenity becomes such a challenge within a strong climate of negativity?

Does fear have any positive value? Yes! Alerting us to danger, exercising discernment to insure safety, and weighing the consequences to impulsive actio

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

Examples of combination products may in

s. Fear can be a motivating energy for action and change. When fear is allowed to control the quality of our lives, then we have a problem. So, to what extent DOES fear rule your life? Exploring your fears in greater depth can be revealing in helping you to

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

understand yourself better. Shifting perception and taking action is evolutionary. In my coaching practice, the energy of fear repeatedly emerges when clients envision (anticipate) change in their lives and literally take steps to bring those changes into re

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

lity. Familiarity fosters comfort and safety; therefore change can be perceived as both frightening and threatening,

Recognizing some of the subtleties of fear takes a bit of detective work. A master of disguise, some of the forms of fear include: procrasti

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

Combination pro

nation (with the purpose of delaying action), the NEED to be in control, anger (can be a cover for other emotions especially helplessness or powerlessness), isolation, induced illness, rationalizing, blaming etc. Getting UNDER the reaction unveils the fear.

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

orking with people has given me innumerable opportunities to witness ways to transform fear.

One of my coaching clients was feeling stuck and overwhelmed. He felt he had made real progress over the years both personally and professionally. He realized he co

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

ntinually came to a point and went no farther. He felt a duality inside. One part of him yearned to take a leap, the other part convinced him it didn’t matter- his life was pretty good. At the root of his inertia, was fear. His options were clear. He could c

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

ntinue to return to this point, possibly ad infinitum, or…. he could move through his fear and take his life to the next level. After much conversation, he expressed his willingness to work through his fear, finally.

These are the some of the most successfu

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

l steps I have found to transform fear:

* Practice daily gratitude – Recognizing your daily blessings, big and small evokes peace and trust. Taking time to express sincere gratitude generates joy-full thoughts and feelings. Put your attention on the glass h

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

lf full rather than the glass half empty. Fear disappears in the presence of joy.

* Be in faith – Put your trust in your spiritual beliefs. Your own personal history reflects the blessings and gifts you recognize as coming from the Divine. At times of doubt

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

Following aspects would a

and fear, draw on your truth for perspective and wisdom. Combined with gratitude, asking the Universe for love, support and guidance has been a great source of comfort and strength in diffusing fear. In faith, there is no fear.

* Be in the present – In a gr

dd to the challenges in developing combination products:

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

ound breaking book, The Power of Now, by Eckhart Tolle, he advocates being in the moment, in the NOW. He stresses the power the mind (ego) has in creating our perceived reality. Our minds have the ability to imagine the worst (intensifying fear), instead of

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

xpecting the best. He says " the more identified you are with your thinking, your likes and dislikes, judgments, and interpretations, which is to say the less present you are as the watching consciousness, the stronger the emotional energy charge will be, wh

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

ether you are aware of it or not." He believes " unease, anxiety, tension, stress, worry – all forms of fear are caused by too much future, and not enough presence." Become an observer to inner thoughts and feelings without engaging or judging, and the thoug

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

t will quickly subside (because it isn’t given any energy to thrive). Being in the present connects us with the Divine.

* Practice extreme self-care – I use extreme because taking the best care of You is serious. When needs are not being met, negative thoug

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

Professional from academic institutions, pharmaceutical industries, health care indust

hts and reactions intensify. Over time, unmet needs can manifest medical and psychological conditions. Have you ever noticed how your life flows (or doesn’t flow) when you are neglecting yourself? Being positively selfish and putting yourself first gives you

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

the vitality and desire to be fully there for those you love- by choice not obligation.

* Be in integrity – Is your life a reflection of your personal standards and values? When you live your life by being true to "who you are" fear is replaced by peace and

.

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

serenity.

* Build a strong, positive, nurturing community – We are influenced and impacted by the people in our lives especially within our inner circle. Allowing the special people in your life to love and support you is a gift and a blessing from which t

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

Companies that provide selfless information through particip

draw strength, clarity, and courage.

* Be a risk-taker, MOVE!- Taking appropriate, empowered action " in fear" dismantles the illusion of paralysis and power of fear. Use your fear to move and take action, one step at a time.

Copyright 2001, Lorraine Cohe

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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