Main Subject - Internet and Businesses Online

Many people get online and get sucked into political forum debates, where one

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

side rails against another. Then the name calling starts and degradation spira

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

Examples of combination products may in

s out of control from there. Eventually people no longer use their real name o

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

identity and then they are suddenly emboldened by the anonymity to say things

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

they would never in a million years say in public.

The sound and fury is fun

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

Combination pro

o participate in, yet having been involved in these things and then finding ou

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 I am debating with an anonymous poster who resorts to name calling is not so

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

much fun. Indeed one has to ask them selves; are you sure you wish to beat you

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

head against the wall, with others who disagree with you? I have noticed atta

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

ks on my personal and actual observations when the other debaters have failed

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

o observe themselves and then basically spout party-line politics for issues t

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

Following aspects would a

hey no nothing about.

Politics are more of a hobby for me, just something fun

dd to the challenges in developing combination products:

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

to think on, I never get too worked up over any of it. People just do not know

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

what I know and have not seen all I have seen, so I understand that. And tryin

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

to convince someone with a closed mind of anything is a wasteful activity. Yo

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

may find yourself in such debate online and you will remember what I have sai

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

Professional from academic institutions, pharmaceutical industries, health care indust

d. We must all agree that there are important issues we MUST address as a Nati

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

n because our security and on-going efforts to maintain our civilization and b

.

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

tter it are at stake. There are serious topics we can all discuss online and w

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

Companies that provide selfless information through particip

have come to far to throw it all away or backtrack now. Consider this in 2006

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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