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NO, I am not a Commie, foreigner or an acid head! I am a business consultant, world traveler, and TEACHER!

For forty years, in my classes in grades 1-12, where I was a full-time, or part-tim

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

e or substitute teacher, I GLADLY held and RECITED the pledge of America. I did so with honor in my soul and a smirk on my face, realizing that few others could have the power and equity in

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

Examples of combination products may in

heir lives as our US Constitution guarantees its citizens!

I will admit that my knowledge of geography and political science has been weak until just a few years ago–my dad left a hint of his

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

love of geography with me when he was alive and I am just now “catching up.”

What provoked my CHANGE from defender of the realm to doubter of the land was the simplest event; I am a speed wa

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

lker and I walk several miles daily. One day, a decade ago, while on my walk, I sped by a car parked nearby my home. The seal on the door caught my eye and forced me to slow down and re-rea

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

Combination pro

it: “Navajo Nation.” I thought, concurrently, two opposing thoughts;
A; I know where that is
and
B; That can’t be right!

I stared and stared and then, continued on my walk.

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

know that Navajos are a component of what Chris Columbus identified as Indians when he founded [by his team] the US in 1492. He of course, was seeking India–thus, Indians! He found the nat

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

ives of San Salvador [later called “Native Americans.”]

Indians, in the United States, are part of the social/political ground called Native Americans and became a sub-set of something or ot

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

er and then, “supervised” by the Bureau of Indian Affairs and The Bureau of Land Management, et al, over the past fifty years.

Now, here is where my brain had a problem as I read that door se

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

l; Navajo Nation, not Native Americans. While Indians in the US ARE native Americans, they are also part of one of 125+ Indian Nations. NOT Indian fun groups, not Indian clans or association

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

, but Indian Nations. N A T I O N S.

But the US is a nation. Canada is a nation. Et al.

When I spoke my pledge, over the past 40 years as both student and again as a teacher, I repeated t

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

Following aspects would a

he words we all repeat; “...one nation, under God....” Ok, my nation is the United States of America. That was easy to identify! I was born in Los Angeles County, California, USA. I was n

dd to the challenges in developing combination products:

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

t a Native American but born a native American. Odd title.

Now, if the Navajo and Arapaho and Puma and the other 100+ Indian Nations are just that, Nations, how can our pledge to the flag ac

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

urately state “One Nation Under God,” instead of a more accurate pledge being “132 Nations under God!”

Yes, I agree, that does sound a bit hokey but we are not legally or politically one nati

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

on– or –the Navajos and Puma and other Indian Nations are not legally Indian Nations. They have their own constitutions, judges, police and more. About 20 years ago [and our press logically

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

made a big deal out of it] our FBI entered a casino on the Ft. McDowell Reservation to remove “Illegal gaming machines.” It turned out, the FBI had no jurisdiction on that reservation! How

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

Professional from academic institutions, pharmaceutical industries, health care indust

ould the FBI not have jurisdiction? The answer is, those entitles that are legally sovereign parts of or are fully sovereign nations, are places where the FBI must get state department permis

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

sion to enter.

So, back to square one. As I ask my students, or TELL my students, regardless of agreements between the state department and the Bureau of Indian Affairs and Bureau of Land Ma

.

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

agement, is the land between [how I phrase it in my classes] Maine and Florida, and between Georgia and California and Alaska and Hawaii, one nation or a stretch of land housing 132 SEPARATE le

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

Companies that provide selfless information through particip

al nations?

I got kicked out of one school for introducing this unique legal paradox.

Again, then, is pledging “One Nation Under God” a current fact or a hope? If a hope, it is not a pledge

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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Most people have a lot of nice things to say about nursing. This could be one of the things that made nursing an interesting career option. But, did you know that there are a lot of areas of specialization in the big world of nursing?

Who is to bless and who to blame? Does your organization have answers or excuses?

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