Suggest - Self Improvement

I messed up the other day. I was in a meeting and I responded badly to something

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

that someone said. I gave a knee jerk reaction, rather than a thoughtful respons

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

Examples of combination products may in

e. I know better, but I didn’t do the better I know.

It has become a legendary

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

story that when Vince Lombardi took over as head coach for the Green Bay Packers;

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

they were in a ten year loosing streak. They had hit bottom in league standings

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

Combination pro

and team morale. At practice, Lombardi called the team together in the center of

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

the field. Then he knelt down, picked up the pigskin, and said, "Let's start at t

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

he beginning. This is a football. These are the yard markers. I'm the coach. You

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

are the players." He went on, in the most elementary of ways, to explain the basi

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

cs of football to those who had played the game for years.

For reasons I don’t u

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

nderstand, it is inevitably the failure to follow the basics that gets me in trou

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

Following aspects would a

ble. It is true at home, at work and everywhere I go. The basics aren’t complicat

dd to the challenges in developing combination products:

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

ed. They are given to us as children. I used to say it is too bad we don’t get a

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

n “owners manual” for life. I now think that is so, because it so incredible simp

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

le. If I were to write my own manual, it wouldn’t be complicated or long. It wo

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

uldn’t need to include much more than the following:

Listen
Think before y

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou speak
Judge not
Treat others as you wish to be treated
Treat

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

yourself as you would like to be treated
Always say please and thank you <

.

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

br> Celebrate differences
Drink Water
Read more than you watch

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

Companies that provide selfless information through particip

Practice
Don’t leave the seat up

Basically, I think those about cover it.

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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