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For a long period of time I had a nagging feeling I’d lost something very dear to me. I’d wake up in the morning thinking I’d dreamed it. But the feeling haunted me throughout the day, day after da

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

y. After a lot of thinking out loud I came to the conclusion that that sense of loss was my own personal freedoms.

At the beginning of the American Revolutionary War Thomas Paine was an activist

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

Examples of combination products may in

writer in support of independence from the British. His articles were not only an inspiration to other Founding Fathers, but more importantly to the common butcher, baker and farmer. Today Paine is

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

probably remembered most for his famous words, “These are the times that try men’s souls.”

Two hundred thirty years and numerous bloody wars later, we are witness to the once stalwart moral fibe

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

of the country, the American middle class, morphing into something yet to be defined, but certainly something less than it was. These too are trying times, and maybe what our souls need is a rev

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

Combination pro

lution of a different kind—a constitutional amendment banning the right to vote to any American citizen who does not vote. Whew!

Would we allow our congressional representatives to get away with t

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

at sort of claptrap? I doubt it. Yet we watch like glassy-eyed cattle our taken-for-granted freedoms evaporate. Each day the list gets frighteningly longer.

Victims of our own genius, sophistica

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

ed technology makes our most private information public. Aided by mega telephone companies, the Internet, satellites and spy stuff we are not even privy to, our homes are no longer our castles. T

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

ink about it. Personal medical records, financial information, social security numbers, phone calls, books we read, how much we pay for our houses, our brand of toothpaste and bra-size are availa

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

le to any peeping Tom who cares enough to have the very best. That’s the short list.

Can you jog in your neighborhood park day or night? Can your kids walk home from school alone? These everyday c

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

oices seem to have quietly slipped away from us when we weren’t looking. Have you noticed more scams than ever in the history of the world? Do you know what your teenagers are doing on their comp

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

Following aspects would a

uters? Have you heard yourself say, “You can’t trust anybody anymore?” Then ask yourself what you can do for your country—and your own self-interest. It’s a no- brainer.

On Election Day, no matte

dd to the challenges in developing combination products:

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

what your political ideology—do not walk— run to your poling station and Vote. It’s the single most powerful tool citizens have. People who throw away this freedom of choice like it was garbage a

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

e usually the ones who do the most whining about what is wrong with the country.

It’s easier than ever to find out who the candidates are, how they vote and what they stand for. Your personal serv

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

nt, the Internet, is at your fingertips 24/7. I came of age hearing my parents talk about Franklin Roosevelt, a flawed yet dynamic personality who, like Ronald Reagan, was a great communicator. F

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

R’s Four Freedoms, painted on canvas by illustrator Norman Rockwell for the “Saturday Evening Post,” are not just high-minded ideals; they are the concrete material principles that Thomas Paine a

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

Professional from academic institutions, pharmaceutical industries, health care indust

d his band of brothers would have applauded:

1. “Freedom of speech and expression

2. Freedom of every person to worship God in his own way

3. Freedom from want—individual economic security

4. Freed

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

m from fear—world disarmament to the point that wars of aggression are impossible.”

FDR emphasized that his was “no vision of a distant millennium,” but rather a world attainable now, in our time.

.

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

Granted today “our time” is global, more dangerous and complex. But serious illness of a physical, economic and political nature often requires bitter medicine to exact a cure. Vision plus guts a

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

Companies that provide selfless information through particip

e the cures, the kind of leadership we must send to Washington to represent us at home, before the voice of the people is nothing but a whimper from a distant past.

“Simplicity-Courage-Humor-Soul”

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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I am writing this to shed some light on the complex (and somewhat confusing) topic of credit repair.....First things first. What is on YOUR credit report? By Federal Law...

Here are a few things that you need to know about interest only mortgage loans before considering them.

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