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What’s a cosmic 2 x 4 you ask? It’s actually a phrase that’s been used in the ‘new age/ metaphysical’ world for

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

the past 15 years or more. It refers to the lessons we learned the hard way when we didn’t listen to our int

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

Examples of combination products may in

uition.

In the process of our spiritual growth and intuitive development, we learn to listen more deeply and f

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

ollow the guidance that comes from within. Because conscious awareness is building during that time, whenever

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

we choose not to listen and go against our intuition, the lessons learned seem twice as powerful and painful

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

Combination pro

than if we had listened.

When it happens, it feels like a 2x4 hitting you right between the eyes. It’s especia

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

lly powerful because ‘you should have known better’. These are lessons that are meant to get our attention ei

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

ther consciously or intuitively. From personal experience I can say it is infinitely preferable to have it come

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

through the intuitive realm, then take action upon it. Choosing to ignore, or bypass your intuitive sense wil

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 have repercussions that can lead to self deprecation and resentment.

Our inner guidance system always has ou

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

r best interest at heart. It ALWAYS knows what direction to lead in. It’s when we don’t listen that we steer

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

Following aspects would a

off course. Usually those sort of off-road detours are very bumpy and filled with potholes. Instead, learn to

dd to the challenges in developing combination products:

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

use the cosmic 2x4’s for conscious construction.

What is conscious construction? It’s the process of building yo

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

ur inner structure in a deliberate and focused fashion. That means learning your lessons, enhancing your list

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

ening skills and embracing your inherent wisdom.

Each lesson we learn is a 2x4 added to our foundation, the ba

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

se of our inner structure. We grow, learn, evolve and build a sturdier structure as we do so. Cosmic 2x4’s ar

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

Professional from academic institutions, pharmaceutical industries, health care indust

building materials for our conscious construction project, along with consciously learned lessons, spiritual

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

growth, etc.

As we build our inner structure we feel stronger, more secure in who we are and more sure of our

.

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

place in this world. Knowing who you are, why you are here and where you are headed is a good feeling. Remem

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

Companies that provide selfless information through particip

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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