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Opening Note: I visited New York City for the first time in February, 2001. My wife and I only had a short one day to discover the Big Apple. It was cloudy and it rained the whole day.

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

We had no umbrella. We got soaked and were cold. But we loved it!! The City has a certain personality, a life of it’s own, and I was completely captivated the entire day.

We only had ti

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

Examples of combination products may in

me to do one building observation deck that day. I chose the twin towers of the World Trade Center. While we were “on top of the world”, I looked across at the Empire State Building and a

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

dmired the view. I remember looking down and thinking how far it was to the ground, as a tingling sensation ran up and down my spine.

As we were enjoying the view, I discovered I had misp

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

laced my wallet. My wallet had all of our trip money – all cash- inside that wallet. In somewhat of a panic, we contacted Security. Yes, the wallet was found and turned in. Yes, they we

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

Combination pro

re holding it for us. We were cordially invited into the hub of security, where we got to meet those who were in charge that day, and they returned my wallet. It still had all the cash in

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

it. We were impressed!

Just a couple of weeks ago, my wife, my youngest daughter, and I were on the observation deck of the Empire State Building. It was our first time back to the Big

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

Apple since that day in February of 2001.

I looked out over the landscape of the beautiful city, and I couldn’t help but notice the missing World Trade Center. I pondered the events of th

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

at day, so long ago, when those people were so helpful to us, strangers to us at the time, and made our trip so pleasantly complete. It was a solemn reminder to me that I do not know the f

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

ate of those people who had helped us that day.

The attack on the World Trade Center on 9/11 was more than an attack on my country. It was personal. Very personal.

The religion of terro

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

rist militants is not the religion of Islam.

Terrorist militants have a self-devised religion of self-serving aggrandizement and cowardice having no morality and recognizing no authority.

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

Following aspects would a

Their god is not the God of Islam. Their god is a god of cowardice, random cruelty, and a pathetic vermin full of lies and deceit. A whimpering coward with a stature of microscopic propo

dd to the challenges in developing combination products:

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

rtions.

The god of terrorist militants is not dead, but is “death” itself. It cares for nothing and no one, and as with al-Zarkowai, will be the ultimate cause of the violent deaths of al

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

l it’s followers, to no real reason or significant purpose.

They will just be dead.

When individuals choose to follow gods of darkness they have no vision and they have no future. They l

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

ose their will to act for their lives are swallowed up in a pit of despair and destruction. They have no joy for they have no Light.

They willingly surrender their freedom and their will

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

to the power of evil.

Preying upon the weak and defenseless, they consider it brave when many of them overpower, bind, torture and kill single individuals. It sure requires a lot of coura

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

Professional from academic institutions, pharmaceutical industries, health care indust

ge for a pack of hyenas to attack an injured fawn. How proud they must be! They are lower than the dead-end back alley bullies who can only bleed strength in their cowardly numbers.

Then

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

they slink away into the safety and darkness of anonymity.

They claim to have a cause. There is no cause upon the face of this earth that supports such deficacious acts of cowardly chaos

.

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

.

The terrorist militant may smile in the steamy darkness like a roach in a manure hole with smug satisfaction, thinking they are not seen, they are not known. But the God of this earth w

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

Companies that provide selfless information through particip

ill have His day of judgement and retribution. The blood of the innocent will cry from the earth against their murderers to bind their hands and sever their soul.

God will give us justice

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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