Advice Pool - Reference and Education

Not long ago I was in San Francisco talking to a Psychic near the old famous pier she was a nice lady and enjoyed

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

her Chinese Clientele in the area many of which were not in the United States legally, but knew they could not b

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

Examples of combination products may in

sent back because China would refuse to take them and it costs the US too much to ship a human being half way ar

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

ound the world.

We were talking about her Chinese customers when our session started and I ask should we worry a

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

out China, as it is the Year of the Pig and that is said to be a problematic year of challenges. The Psychic told

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

Combination pro

me not to worry about China or the Year of the Pig. Well that was nice to know because I really worry about thei

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

financial market collapsing because of their unfortunate and troubling choice to manipulate their currency.

I 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

sked her if there was anything to worry about with China? She looked into her crystal ball and said yes, lots of

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

cary stuff and there are about 15 behind the scenes reasons, but she said her crystal ball was being clouded by a

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

n evil force and suggested I pick up a copy of Soldier of Fortune Magazine that has some even more scary stuff in

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

it. I asked like what?

She gazed deep into her crystal ball and said like the hand-held Chinese surface-to-air-m

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

Following aspects would a

issiles that China is selling to Iran, which Iran is smuggling into Iraq to shoot down our helicopters. Then she

dd to the challenges in developing combination products:

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

aid you have a brother in the Middle East don’t you? I said yes and she said I see him and he is fine, he is in t

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

he USMC isn’t he. Wow, this psychic was spot on.

The psychic then made a very interesting comment on a very touc

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

y subject and she said China is a political football behind the scenes. Everyone knows what’s going on and they a

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

re changing, but the march toward world domination. She said I see evil in my crystal ball and it is only with a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ew long-term plan strategists in their elite Military forces.

She then said; "There is more than one face to the

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

dragon" as here eyes turned aqua blue and then like glass and I saw what she saw and I will never forget it. I c

.

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

rtainly hope this article is of interest and that is has propelled thought. The goal is simple; to help you in yo

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

Companies that provide selfless information through particip

ur quest to be the best in 2007. I thank you for reading my many articles on diverse subjects, which interest you

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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Advice Pool - Psychic Tells Man Not to Worry About China or the Year of the Pig

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