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Social Articles - Big Idea # 1 - Let's Simplify Politics!
My hat is off to any person who can tackle a complicated problem, boil it down to its basic basics, and render it digestible, accessible, and understandable to the average Joe on the street in ord
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
er to inspire action of the right kind. In this regard I'd like to introduce you to a friend of mine named John P who has done precisely that with the totally confusing and frustrating subject of
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
olitics.
To use John's own words, "In school they always talk about the three R's...reading, writing, and arithmetic. But in politics it's all about the three E's... the environment, the economy,
To use John's own words, "In school they always talk about the three R's...reading, writing, and arithmetic. But in politics it's all about the three E's... the environment, the economy,
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
and education." Let's take them one at a time.
The Environment is E # 1. And most people, with any degree of common sense at all, will readily admit that clean air, clean drinking water,
The Environment is E # 1. And most people, with any degree of common sense at all, will readily admit that clean air, clean drinking water,
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nd rich soil in which we can grow crops are pretty important issues for the human race, not to mention every other species on the planet. If we continue to screw up the environment in the name of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
evelopment, of any kind, we do so at our own peril, and future generations will be the ones to pay the price for our self centered lack of foresight. It's just plain dumb to do anything other than
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
cooperate with Mother Nature because if we choose to compete, we choose to lose.
The Economy is E # 2. In short politicians (or anyone else) can talk about the environment, they can talk
The Economy is E # 2. In short politicians (or anyone else) can talk about the environment, they can talk
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
bout education, health care, terrorism, crime in the streets, government corruption, family breakdown, abortion, and school prayer...etc., but without the ability to pay for what needs to be done
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
on these issues, we're all just talking. It’s nothing but talk, and talk is cheap.
In other words, if the economy is hitting on all cylinders we can pay for tackling all kinds of problems. But wi
In other words, if the economy is hitting on all cylinders we can pay for tackling all kinds of problems. But wi
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
thout a sound economy, without the ability to pay for pro-active initiatives, it's total BS. The difference between "cheap talk" and "legitimate action" is a sound economy. It's that simple.
E
E
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ucation is E # 3. But I'm not talking about the conventional indoctrination and bull manure that we label education in the 21st century. You know, the 12 to 20 years worth of classroom class r
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
om experience that systematically grinds our naturally round pegs into entities that fit neatly and efficiently into square corporate holes, and underwrites the status quo regardless of what it's
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
doing to people around the world.
In contrast, I'm talking about real education that encourages real questioning, real thinking, and real practical understanding of real problems. That is to say,
In contrast, I'm talking about real education that encourages real questioning, real thinking, and real practical understanding of real problems. That is to say,
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
if there are real 21st century answers to real 21st century environmental and economic problems, people must be able to understand them if they are going to implement them and if they are going to
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
have any positive and practical effect on our world. The education that allows that kind of understanding is what I have in mind when I talk about E # 3.
In Summary: I'd like to meet the
In Summary: I'd like to meet the
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
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
politician who will cut right to the chase and say "Look folks, there are only three real issues out there that we really need to address. First we must secure the environment for without it we're
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
toast. Second we must discover how we can democratize the free market (the $64 trillion dollar question of our age), and pay for the things that we need to do as a nation and as a world. If we fai
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
in this endeavor, everything we do is little more than idle chatter, designed to confuse and frustrate voters who are already totally confused and frustrated.
And finally, the people must be abl
And finally, the people must be abl
.
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
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
e to understand what needs to be done to salvage the environment and to rectify the economy. If people fail to understand, there can be no mandate from the people, in which case there’s no legitim
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
cy to what we like to call America’s democracy. On the other hand, if we get a handle on the three E's, then we can discuss the other issues, they’ll make sense, and we can vote intelligently. Ame
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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