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“We’re one, but we are not the same.”—Bono, U2

Once I was in a train station waiting for a train with a friend. He pointed to a steel and cement column and said, “at the sub-atomic level, this column i

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

s mostly air. So are you. So am I…”. And he went on to state we were the same as the column—no difference—and no different from one another. He went on to imply that there was, therefore, no meaning

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

Examples of combination products may in

to anything. I stretched my arm out, made a fist, and pushed my fist at the column until it stopped with a thud. I looked at him and I said, “that may be so, AND at the same time, the world we move t

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

hrough is not the sub-atomic world”.

Often we are addressed with reminders, assertions, and at times even pleas, that we are “all one”. We are all human. We are all the same at some level. We all ble

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

d red. At the sub-atomic level, we are all made up of the same stuff. In fact, at the sub- atomic level, at least at our current level of knowledge [see String Theory for an interesting hypothesis ab

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

Combination pro

out how we may be very different from one another indeed], not only are we all “the same” as beings, we are the same as a rock, dirt, plant life, our dog, the wall, etc.

Eastern Spiritual traditions

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

remind us that at the ultimate level, it is all vibrations, all wavelets. "Validated" by science, at the “ultimate” level, we are all the same—“just” sub-atomic particles.

And yet, anyone with eyes,

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

ears, a tactile sense, and a mind can tell we are all very, very different. I challenge anyone who says that the ultimate level is the only important level (“we are all one”) to Zen his or her way thr

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

ugh me the next time we meet.

The problem with this is that most people cannot seem to contain both I.D.E.A.s intellectually, experientially, or spiritually, so then end up ignoring one or the other,

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

or collapsing the informational and the practical. Does our having the same sub- atomic structures mean we are all the same?

Are you “the same” as a murderer? A rapist? A child molester? A terrorist?

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

A priest? A politician? A man? A woman? A tribal leader? A shaman? A grocery clerk? A Fortune 500 CEO? Are you and I “the same” as Mozart, Bill Gates, Socrates, Thomas

Jefferson, or Ayn Rand? Of cou

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

Following aspects would a

rse not.

And, yes.

We have differing sets of skills, intelligence, symmetry, size, shape, and color. And yet...to paraphrase Ken Wilber, “while we are all perfect manifestations of the divine —of Spi

dd to the challenges in developing combination products:

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

it—yet how we demonstrate that is bound by our current level of development; we are limited to our current depth”. Spiritual reductionism [we are all one and we are all perfect and we are all love] is

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

usually accompanied by moral relativism. No act is inherently better than any other act. No world-view is more true than any other—and they are arbitrary.

I disagree.

Setting aside the performative

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

contradiction (if no world-views are any more true than the other, then neither is that world-view—and thus it is false), compassion is better than anger because it possesses greater depth. Love is b

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

etter than hate for the same reason. Grace is better than vengeance for the same reason—it requires an awareness of greater depth to exercise those choices, therefore, it is better.

Liberty is better

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

Professional from academic institutions, pharmaceutical industries, health care indust

than tyranny. Free Enterprise is better that centrally planned economies. In both cases they produce better results. Measurably better. Different beings possess different levels of awareness; differen

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

t depths that that can reflect back by the development of their own depth. In this, we are very different indeed.

Is there utility in thinking we are all one—all the same? Perhaps. It can assist us in

.

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

bridging potentially explosive differences in a world where differences in ideology can kill and maim. At the same time, in a world where ideologies can kill and maim, we had better keep the differe

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

Companies that provide selfless information through particip

nces in mind as well.

In all things, be discerning, but not judgmental. Keep your mind open—but keep it working. Never allow someone to demand you turn off your common sense for their imagined utopia

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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Many Americans receive health insurance through their jobs or enjoy its benefits because a family member has insurance at work. The least expensive of its kind, this is known as group insurance. In a number of instances, the employer bears part or all of the cost.

Have you read of the poor high school graduation rates? Are you puzzled to the why behind this poor performance? The problem appears to be more about bad attitudes than anything else.

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