Advice You - Business

We Americans celebrate at least a dozen holidays each year. And while only Christmas seems to bring most business (and other activities) to a halt for at least p

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

art of a day, each holiday should represent at least a heartbeat's pause for those of us celebrating to remember who and what the celebration is all about.

If it

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

Examples of combination products may in

s worth celebrating, it should be worth knowing why we are celebrating. How can we better focus on celebrating those whose births, careers, or accomplishments, t

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

he day commemorates?

This month, I wonder how many of us really think about Martin Luther King on his holiday? And if we do, are we really aware of what are we

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

elebrating?

On January 15th , we will celebrate a holiday that more than any other, asks us to stop and remember that opportunity in America is, indeed, for ever

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

Combination pro

yone. Certainly it recognizes a distinguished African-American. But the holiday is about opportunity. It's about the promise of America. Martin Luther King Da

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

celebrates a man who died to strengthen the belief in the American Dream. In this year, of all years, we need to be mindful about the promise that is America, l

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

est in forgetting, we lose something precious to us.

This year, we are 300 million Americans strong, and we represent about 4.6% of the world's population. Rich

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

and poor, fat and skinny, white, black, brown, red and yellow. Americans make up the richest, mostly, self-sufficient market on the globe. Immigrants come here

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

for opportunity, through largely "open doors," that some would close. Immigrants – and we were all immigrants at one time – come from every nation. Some speak

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

f freedom and opportunity. Some speak of equality and opportunity. All speak of a better life and that is opportunity. Since 9/11, we have questioned how much t

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

Following aspects would a

o change our policies, whether to remain as open as in the past. We have become more restrictive, not just more careful. Is this a path that will best nurture t

dd to the challenges in developing combination products:

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

ose who have dreams of opportunity? Are we still willing to pay the price our patriots and our citizens at arms have had to pay to ensure our freedoms continue?

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

Our self-sufficiency has made us strong; it has its dark side as well. At its worst, as before both World War I and World War II, it nurtures a dangerous "us-th

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

m" isolationist mentality that is unsustainable in today's global economy.

Once upon a time, I read about a merchant who didn't want to sell to a certain minorit

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

y as his neighborhood changed. Their money was the same color as his but their skin wasn't. He discouraged them from coming into his store so they went elsewher

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

Professional from academic institutions, pharmaceutical industries, health care indust

. This merchant was blind to opportunity, to learning and to growing. Some time later his store went broke, replaced by a store whose owners catered to everyone.

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

Good humanity proved to be good business. Within 3 years, these new owners had three stores throughout the neighborhood.

Celebrating Martin Luther King Day isn

.

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

t about black and white, or any other color, religious belief, or culture, for that matter. It's about opportunity – opportunity to become all that each of us ca

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

Companies that provide selfless information through particip

n become. It's about seeing the "person" in each of us. We need this holiday. We need to be mindful of its purpose. It's good humanity and it's good business

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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