Main Subject - Business

In Guys and Dolls, there is a character named Nicely Nicely Johnson. Perhaps

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

most memorably portrayed by Stubby Kaye, Nicely Nicely earned his name by alwa

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

Examples of combination products may in

ys responding to “how are you?” with “nicely nicely thank you.”

I am concerne

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

that nice people will soon be placed on the endangered species list. Certain

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

ly, I know nice people, but when I watch people’s behavior, I can’t help but r

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

Combination pro

call humorist Dave Barry’s insight, “A person who is nice to you, but rude 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

the waiter, is not a nice person.” I think we could all use a little more nic

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

ely nicely.

The behavioral qualities associated with being nice are not diffi

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

ult to employ. They may come naturally to some, but for me, it can take a lit

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

tle conscious effort. I have attempted to define those qualities in a “N-I-C-

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

” way. Perhaps if they are more easily remember, they will be more likely emp

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

Following aspects would a

loyed.

To be NICE involves:

N – Be Non-judgmental Most of the time, confli

dd to the challenges in developing combination products:

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

ct and stress is the result judgment. Being non-judgmental makes life much eas

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

er.

I – Be Interested People’s lives are truly fascinating. Show a bit of i

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

nterest and most will share wonderful stories.

C – Be Complimentary Chris Roc

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

said, “There are only three things women need in life: food, water and compli

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

Professional from academic institutions, pharmaceutical industries, health care indust

ments.” It’s true for men, too. People are hungry for sincere compl

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

iments.

E – Everybody Nice means being nice to everyone, even those who mak

.

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

it difficult.

Today is a great day to choose to be Non-judgmental, Intereste

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

Companies that provide selfless information through particip

d, and Complimentary to Everybody. That will do quite nicely nicely thank you

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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