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Un-communicated feelings mean squat! People don't know how you feel until you tell them how you feel. Over twenty years ago my best friend died

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

of cancer. Randy was 41. He was successful, competent, always positive and loved and lived life to the fullest then he was gone.

There was one

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

Examples of combination products may in

thing missing in his life. In 41 years his father was never able to tell him that he was proud of him, loved him and believed in him. That was

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

the only thing Randy ever wanted from his father and in 41 years he never got any of them.

At his funeral I am convinced, that if his father cou

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

d have waved a magic wand over his casket and had one wish, it would have been to have one more chance to tell his son how special and loved he

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

Combination pro

was. He'll never get that chance. It is too late for him. He will live the rest of his life with that regret.

For three years while Randy wa

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

fighting the cancer with every fiber of his being, every time I say him I gave him a bear hug and told him how special he was, how much I loved

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

him and how proud I was of him.

Randy has been gone now for sixteen years. I miss him. His father misses him, but I don’t have to live with th

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

regret that I never told Randy what he meant to me. His father does.

It may still not be too late for you.

Is there someone in you life, anyo

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

ne, that would love to or needs to have some special words of love, encouragement or support from you. Is there someone that deserves and wants

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

to hear the words and not have to "just intuitively know" how you feel. Life speeds by leaving many un-said words in its wake. The ground is li

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

Following aspects would a

tered with dead intentions of words not spoken – deeds not done.

Again, people don't know how you feel until you tell them how you feel.

How ab

dd to the challenges in developing combination products:

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

out you?

I'll bet there is someone you can call, visit or write to that once done, would make their day as well as yours brighter and possibly

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

ontribute to long term peace in your life as well as theirs.

Don't wait. Do it now. There is still time for you.

Time passes, all too quickly

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

for all of us my friend. Blink - your best friend is gone. Hesitate - your parents are gone. Pause - your spouse, children and sibling are go

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. Negative? Depressing? Sad? Painful thoughts, yes, but theses are nothing compared to the lifelong regrets that you will suffer with words l

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

Professional from academic institutions, pharmaceutical industries, health care indust

eft unspoken. Don't wait until it is too late. I am sure there is someone you need to call today to tell them how special they are and that you

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

love them. Don't wait another minute. Time is running out.

If you have lost someone recently I would urge you to buy my book, The Last Goodbye

.

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

, Saying Yes to Life After The Loss of a Loved one. You can get it on my website.

Remember Harry Chapin’s song, Cat’s in a Cradle? If you are

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

Companies that provide selfless information through particip

oo young to remember it find it somewhere and listen to it. If you remember it, why not dust it off and listen one more time!

Have a great week

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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President George W. Bush has likened the war on global terrorism that he initiated to the war fought by the first American president and his namesake George Washington to promote freedom worldwide. He made this comparison while honoring the 275th birthday of Washington whom Bush called “the father of our country” in Mount Vernon in time for the national Presidents Day holiday on Monday, February 19, 2007. Bush said “Today, we’re fighting a new war to defend our liberty and our people and our way of life. We remember that the father of our country believed that the freedoms we gained in our revolution were not meant for Americans alone.”

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