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In the world today, particularly in this country, there seems to be total obsession with the most trivial of affairs in every day life. In the midst of int

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

ernational disasters, there seems to be unhealthy interest in the incarceration of a totally self-indulgent offspring of one of the nation's oldest and mos

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

Examples of combination products may in

t aristocratic families. In the midst of world turmoil, is this really that important?

With the pending national election of a new president, and a large

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

number of candidates in the race, much more television time is given to the childish cat fight of a pair of stars of a daily talk show, supposedly for the

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

emales of the morning. These two allegedly intelligent ladies of the morning talk show became embroiled in what might be considered an exchange of words th

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

Combination pro

at would have been appropriate to the green room and not aired on national television. To borrow a phrase from a well know tele personality, "Give me a bre

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

ak!"

But this little nonsensical exchange of words is the talk of the town. Even the Donald got involved. Or, at least, involved himself. Sure does smack

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

of playground spats that we all remember and know about.

The point here, where is all this childish nonsense going to end? Is this more important than the

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

real issues of the nation and the world. In some spots in the world, people are dying and we seem to be interested in a couple of tele hot shots airing the

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

ir differences while we watch with total involvement. Give me a break.

It is time we awakened and smelled the roses. We need to become involved with what

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

is really important and stop being obsessed with triviality. Who should really care when two tv stars air their differences with so such vulgarity. There a

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

Following aspects would a

re so many more really important issues that should, that MUST be addressed. There needs to be a dialogue started on some of the real issues facing

dd to the challenges in developing combination products:

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

his nation. Or, actually, the world.

I realize that what I am putting down here will, in the main, be ignored. This is just a tiny speck in a huge sandsto

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

rm of controversy. Probably it will never become an irritant in the right places. But, if we don't begin taking the time to let our opinions be known, noth

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

ing will happen. There will continue to be more interest in the trivial moments than the really important happening in the world.

I heard the point being

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

emphasized on a television talk show last night that we, as a nation, have ceased to be readers, but watchers. We have become a nation of listeners, totall

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

Professional from academic institutions, pharmaceutical industries, health care indust

focused on being spoon fed all the issues, no matter the importance. And the visual and audio power of this replacement of printed media is stifling the a

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

bility to consider and judge the issues.

This is just a comment. And I know it will be generally unimportant in the main. But a little bit here, a little

.

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

more there, maybe it will pique someone's interest and we can begin a dialogue that will make a difference. And, if someone gets involved and starts that i

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

Companies that provide selfless information through particip

mportant discussion on the issues, this little missile of words will have worked the magic. We need to start thinking, reading, and not be watching so much

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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