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Yes, I know, it's been awhile. I haven't updated or posted this blog for over a month because frankly, I haven't been able to muster the energy or the desire to continue wading through the cesspool some still affectionately refer to as "politics".

On

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

one side you have a group of folks who have sold their souls and their consciences to the far left of their party and would suck sewage through a drinking straw so long as doing so would cost "evil Bush" a percentage point or two in popularity. For G

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

Examples of combination products may in

od's sake, we are a nation at war for our very survival and their most pressing need is picking out drapes and furniture to adorn their offices when they regain power.

On the other side you have a group of folks who have spines made of Jello and seem

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

hellbent on letting the minority party get away with it. I've been having a hard time figuring out which is worse: The party of Bush haters or the party that is enabling them.

Don't get me wrong, there are a few honorable civil servants on both side

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

s of the aisle, but it has gotten to the point that I'm not sure whether I could pay my water bill if I had $10 from each of them.

I align myself with the Republican party first and foremost because they are the most willing to defend this nation fro

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

Combination pro

m our enemies, but even that no longer seems to be set in stone.

You would think using the world's finest and best equipped fighting force to eliminate those who want to kill us would be a no-brainer whether you are a Democrat or a Republican, but de

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

fending America no longer unites us; it divides us.

Today's politicians find a way to continue funding our war efforts then seemingly spend the rest of the time figuring out a way to undercut our ability to win it.

It's all about holding onto power

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

or regaining it. I'm not real sure how useful that power will be if we wake up tommorrow with one of our major cities obliterated because our elected officials are more worried about November than they are September. The threat to our nation is real

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

and it is right now.

I found myself watching the Inside 9/11 series on The National Geographic Channel yesterday and found myself completely caught off guard by

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

one segment in particular: I call it The Chirping Rubble. I'm not real sure if that is the best way to describe it, but those are the words that have been running through my head like a freight train all day and is what led me to write this today. I w

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

nder if our elected officials in Washington have heard the sound of the chirping rubble?

For those who didn't see it, I suppose an explanation is in order:

Near the end of the episode dealing with the eventual collapse of both towers of The World Tr

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

Following aspects would a

ade Center, there was a scene showing rescue workers sifting through the rubble looking for survivors. It was eerily silent except for the chirping of what sounded like hundreds of beepers coming from beneath the rubble. They were the emergency locato

dd to the challenges in developing combination products:

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

rs worn by police officers, firefighters, and first responders who were running up the stairs in an effort to send everyone else down.

Each and every chirp marked the location of one selfless hero who made the ultimate sacrifice for their fellow man.

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

I don't know how many chirps there were, but it sounded like hundreds and was deafening to me.

I honestly didn't think there was anything else that happened on 9/11 that could affect me more profoundly or make the wounds of that day any deeper tha

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

n they already were, but I was wrong. The chirping made the sacrifice of each of those brave souls more real than ever before. I couldn't sleep thinking of the impact it must have had on the rescue workers trying desparately to locate them and hoping

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

beyond hope they were still alive.

Many of the best and bravest America had to offer seemed to be calling out to them from beneath an insurmountable mass of twisted steel and broken glass and yet there was very little that could be done to reach them

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

Professional from academic institutions, pharmaceutical industries, health care indust

in any sort of timely fashion. I can't imagine a more hopeless feeling, and yet I can't remember a more tireless effort in the face of such impossible circumstances.

The chirping served as a reminder that no matter who wishes us ill, there will alwa

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

ys be those among us who will face any foe, stare down any threat, and yes, pay any price so that we all may remain free. The debris may have appeared insurmountable, but the chirping is what left the lasting impression on me.

From now on, when I hea

.

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

r crickets chirping on a warm summer evening, I will be reminded of the selfless sacrifice made by those who gave all for their fellow man that day and those who stand ready and are doing the same today.

It's high time for politicians of all stripes

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

Companies that provide selfless information through particip

to stop focusing all of their energies on regaining power and winning elections and start focusing on defending this great nation from all enemies foreign and domestic. Listen to the chirping rubble and sacrifice your pride for the good of the country

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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