Advice Pool - Reference and Education

What happens when a small segment of our society is outcast and feel alienated? Well, perhaps you have found yourself in such a group previously? Odd man out or involved in an activity, which was different from the norm?

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

Well, it does not seem fair when it happens to you does it? Yet we as Americans are alienated a large group of folks in our society; the gay and lesbian community.

Sure some people say it is justified, I mean that sure

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

Examples of combination products may in

y is a very different lifestyle indeed. And it is so different that many cannot understand it. It causes anxiety and some say fear. You know how those homosexuals like to run around and call everyone a homophobic? Well m

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

ybe they are right and maybe they aren’t but this name calling on both sides has furthered the divide between the group and the rest of America. You might say so what, as it really does not affect our daily lives much do

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

s it? Well true enough, but before you say it is not your problem, realize it seems to affect them very much.

In fact there is a lot of built up tension and animosity out their towards us regular folks from the gay folk

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

Combination pro

. Enough that perhaps we all ought to take notice of potential individuals going out of their way to make a much bigger issue out of it than mere name calling. I had addressed the issue of the more radical gay fringe wit

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

h the gay and lesbian community. They actually believe it does not exist and is no problem to society. Much like the environmentalist deny that the eco-terrorists are arsonists, polluters and criminals. In talking with t

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

e group you know I am really getting bored of their denial of the problematic gay fringe walking around with hate.

You can feel the hate, you can see it in their eyes and hear their thoughts. Indeed their under breath c

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

mments and talk in groups is also troubling. Having had them play their intimidation tactics on me and threatened my person, used extortion tactics against my company, I need not prove anything to the gay community that

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

heir fringe exists. Yet they are in denial of the gay fringe radical fundamentalists and their potential heightened criminal acts in the future.

I hereby predict that someone or a group or a multiple set of groups out t

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

eir will cause a criminal act which will be in the headlines for months, but the gay and lesbian community could have been prevented if only the gay and lesbian community would have done something about it. I can feel th

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

Following aspects would a

e negative energy of some of these folks, if the gay community cannot, then their eyes are closed and they need to wake up. Because as a non-gay I cannot do anything about these folks, but they can, but won't because the

dd to the challenges in developing combination products:

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

gay community is telling me they do not exist.

They are in denial or lying, personally I do not care which. Maybe it is safer for the group to just keep quiet and live in denial. Fine, but the problem festers until the

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

ot boils over and the gay community and all their friends could have stopped it. But cared not to. Too busy with their own lives to care about their treasured gay and lesbian community. And if they do not care, well it s

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

ould be obvious why many of us do not care and thus the rift is widening instead of acceptance and tolerance you see?

I am sorry I call an ace and ace and a spade a spade. I have clearly identified a big and growing pro

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

lem, and with each defeat of the gay marriage makes this gay fringe group grow more and more angry willing to break the law and attack anyone they think a threat. Personally I am tired of the homophobic labels and motif,

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

Professional from academic institutions, pharmaceutical industries, health care indust

I am tired of the name calling and threats and the gay community needs to wake up because so is the rest of America, they are starting to piss people off, some folks who are even neutral on the gay marriage subject. Thi

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

is hurting their cause. So when they say that we need to be tolerant, I say; “Hey wait a minute, you all need to be tolerant!”

You see, now the problem is not only with the meat heads of the Christian Radical Right wit

.

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

their gay bashing BS, now the problem is within the terrorist like gay fringe. Perhaps a defense mechanism, sure could be, but when acts of violence come about, no one who gets injured or killed as an innocent bi-standa

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

Companies that provide selfless information through particip

d really cares who started it. The gay and lesbian community indeed has their work cut out for them, but if they fail to control this fringe, then it will set your gay community back a decade or so. 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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