Advice Pool - Self Improvement

What would your life be like if you live without fear as an issue?

When my son was born, he innately had this ‘edge’. Not in a bad way, but in a way tha

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

t let me and everyone around him know that we should not be fooled by his size. He spoke loudly, played with intention, would shoot baskets until he coul

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

Examples of combination products may in

no longer stand, ride off curbs with his bike, before most were even on a two-wheeler and was very clear about the power he had. Unfamiliar with his way

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

of behaving, we naturally tried to rein him in; trying to slow him down, prepare him for falls, and warn him of failure. But nothing deterred him. Everyd

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

y was a new day for him, completely (it seemed) separate from whatever had happened the day before.

It took six years before I truly understood where he

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

Combination pro

as coming from, as he proceeded to tell me that he was going to wear his dad’s shorts for the day. I figured it was his way of connecting to his six foot

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

tall dad, who had just left for work. I gave him fair warning, my constant attempt to prepare him for failure, that they weren’t going to fit, but he in

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

isted they would.

“Fine,” I said. “Go ahead and try them on.”

He proceeded to pull the enormous gym shorts up, staring in the mirror with a huge smile…

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

.until he let them free and they fell to the floor. I was about to laugh, when I saw the look of horror on his face. This was not a look of failure at h

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

s attempts to make them stay, but yet a look of complete disbelief. He looked at me with a look I had never seen.

“Why don’t they stay on?” he asked wea

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

ly, pulling them again to his hips.

It was then that I truly understood his ability to shoot 100 baskets without caring how many went in. His ability to

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

Following aspects would a

ride off every curb in the neighborhood, with certainty that the next one would not make him fall and his confidence to tell his brothers’ friends (three

dd to the challenges in developing combination products:

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

ears older than him) exactly how the game was played. In that moment, I realized that he saw himself as the same size as Daddy. He did not come into thi

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

s world feeling small, or run by the notion that he had to catch up to everyone around. As far as he was concerned, he was here, because he was meant to b

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

here. And until he knew otherwise, he was as strong, as fast and as smart as anyone else. His size was not a deterrent, because he was as big as whoeve

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

was standing near him.

I watch him now much differently and mostly in awe. He has no fear of failure. His only goal in life is “his attempts.” It’s m

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

Professional from academic institutions, pharmaceutical industries, health care indust

ore than all of the successes he has experienced in the mere 10 years of his life so far, but the fact that every time that ball comes at him, he knows he

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

will catch it. Sometimes he is right. And sometimes he is not. But neither result keeps him from being excited about the next ‘catch.’

I have learned

.

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

to live vicariously through him, supporting all of his attempts, but it’s a lesson we could all learn from. How would your life be different, if we lived

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

Companies that provide selfless information through particip

into the possible success, rather than the possibility of failure?

Today I challenge you to Have No Fear, and see how many more things you can accomplish

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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