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In no other time in history have we as individuals had the power to quickly, easily and

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

for little or no cost reach millions of other people. With a few keystrokes or mouse

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

Examples of combination products may in

clicks we can share with the world our thoughts, opinions, dreams and complaints. We c

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

an express ourselves artistically and experiment with our creativity.

This ability is

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

antastic. I myself have taken advantage of these opportunities and continually write a

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

Combination pro

rticles such as this one or create video logs to express my thoughts, opinions and expe

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

t knowledge. Now don’t get me wrong. My efforts are not purely for a creative outlet.

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

I have something to sell. Not a product, but services. If enough people find my art

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

cles interesting and informative then maybe they’ll think of me the next time they need

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

help in my areas of expertise.

I find that a great deal of people are doing just as I

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

am; sharing their thoughts, ideas and expertise with the intent of letting others know

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

Following aspects would a

more about themselves and ultimately about their professional services. With all this s

dd to the challenges in developing combination products:

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

aring going on, I question sometimes if others are getting the messages.

In other word

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

s, is anyone listening? Those of us who are blogging and vlogging can spend a great am

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

unt of time doing so. With the time it takes to put out a quality product (I do consid

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

er our work products) does anyone one have much time left over to read or watch other p

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

Professional from academic institutions, pharmaceutical industries, health care indust

ople’s work?

Not as much as we’d like, but hopefully enough that we achieve the desire

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

d result. If you’re not doing so already, do set aside some time just to read and view

.

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

what others are doing. Appreciate the time and effort they put into it. I’m sure you’

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

Companies that provide selfless information through particip

ll come away with something valuable. If not knowledge, I’m sure you’ll be entertained

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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