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The point in which your business is running on its own with minimal interaction from you. Is it possible? T

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

hat depends. What kind of a business do you want? Do you want to surround yourself with winners? or Do you

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

Examples of combination products may in

ust want to just cash the checks? Either way is fine, as long as you understand the big picture.

I have be

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

en in the Multi-level/Network Marketing industry for many years. I have had some pretty large success and s

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

me equally large disappointment. I will be the first to take responsibility for the disappointments, but I

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

Combination pro

ill also take credit for the success. I know that when I decided to ignore what was right in front of me an

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

d expect the business to run by itself, I got exactly what I put into it; not much! When I decided to pay a

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

tention, not only to what I was putting into the business, but also the people I was attracting, I received

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

much more than I could have hoped for.

Here is the key: Daily attention is required at first and then it

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

egins to grow on its own. The business is a family. When the child is born, it takes much attention. Feedin

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

it, nurturing it, teaching it. As it grows, it starts to take on a personality of its own with input and g

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

Following aspects would a

uidance. The child becomes aware and learns new things on its own. At some point in time, the child is now

dd to the challenges in developing combination products:

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

n adult and able to replicate the process. Hopefully, we have instilled my passion and desire into the chil

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

d so that it is going in the same direction as us. Now, imagine if you had 2 children, 4, or 8 and they all

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

had the same drive and values as you. Pretty soon you are a great grand-parent, helping to guide and teach

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

our great-grandchildren what you know and have experienced. Your input is still valuable and necessary, but

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

Professional from academic institutions, pharmaceutical industries, health care indust

not nearly as often.

Now a normal family could take 18+ years to start developing. Your business could ta

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

e much, much less time. Personally, I have seen it as short as one day. It all depends on YOU and your pass

.

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

ion for what you are doing. Always remember that your child/business requires care and feeding at first but

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

Companies that provide selfless information through particip

ultimately, it will take care of you. Teach it well and pay attention to its needs. And as always, HAVE FUN

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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As individuals we all operate from our own agendas. How to get individuals to successfully work together for a common goal?

Many taxpayers are confused about what tax records they should keep and for how long. This article provides the answers and highlights a few unique situations.

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