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Am I going to die today? It’s a thought that generally doesn’t run through my head on a regular basis. Should it? Should I be worried? A young man woke

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

up this morning filled with boyhood dreams of flying with the birds and soaring above the clouds. Did he think he was going die today? Probably not, but h

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

Examples of combination products may in

did. Flew his small plane into the side of an apartment building in Manhattan. Terrible accident. Terrible tragedy. He flies no more.

A wonderful woma

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

n I knew, a neighbor, crashed her car on a bridge one rainy day returning home from some innocent shopping. I wonder, as she was brushing her teeth that mo

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

ning and combing her hair, did she look in the mirror and say, “I’m going to die today?” Do you know? Is there a feeling you get?

Did that pilot look up

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

Combination pro

nd see the building before his plane hit? Did he scream? I can only imagine as his plane lost altitude and spiraled downwards, he knew there was going to

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

be a crash. But die? We never think we’re going to actually die. We may get seriously injured but we won’t die. That happens to other people. Not us.

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

e’re a society of risk takers and adventure seekers. We push the limits as far as we can, jumping from planes, diving with dangerous sea creatures, loving

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

every minute of it. But sometimes the parachute doesn’t open and the sea creature attacks and we’re left again to wonder, “Am I going to die today?”

I kno

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

all about death. I watched bed side as disease and sickness ravaged the body and mind of someone very close and special. In this case, she knew she was g

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

ing to die. It was just a question of how long she was willing to fight and let me say, she fought with the courage and ferocity of a lion. When her body

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

Following aspects would a

finally betrayed her and she slipped away, I was devastated but lucky. I had the chance to say goodbye. Tell her I loved her. Tell her thanks for everyth

dd to the challenges in developing combination products:

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

ng. Tell her how proud I was to be her daughter.

People die everyday of sickness or in accidents, because of war and malice. We pause for a moment and sa

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

y “oh how sad” then continue to talk on our cell phones and chomp French fries. It’s so much easier to look the other way and pretend that these tragic thi

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

gs don’t happen to you and me. But they do. All the time. And we never know what to say. Somehow “sorry for your loss” seems so lame. So many times we

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

ay nothing and stand there feeling embarrassed and inconvenienced by someone else’s loss.

I’ll always remember the last words my mom whispered to me before

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

Professional from academic institutions, pharmaceutical industries, health care indust

she died. She opened her tired eyes, smiled and said, “hi”, like today was just any old day. Something so casual, so simple. Did she know those would be

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

the last words she ever spoke? I think she did. She knew her time had come.

When I drive over the bridge where my neighbor died, I always clench the stee

.

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

ring wheel a little tighter, keeping my eyes straight ahead, trying not to envision the accident. I think of her family and a lump forms in my throat. I c

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

Companies that provide selfless information through particip

n’t help it, that’s just the way I am. Then I think of my own family and as I turn off my light to go to bed at night, I’m thankful that I didn’t die today

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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