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Main Subject - Outsourcing of American Corporations; The Real Problem Causing It
As many Americans complain that our Corporations are moving all
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
their manufacturing to other nations and taking all those jobs
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
with them, one has to wonder why is all this happening in the
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
irst place?
Well imagine if you will that you are a corporatio
Well imagine if you will that you are a corporatio
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
n and you are constantly being bombarded with class-action BS l
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
wsuits. Imagine the unending over regulation from all the vario
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
us agencies from the SEC on down?
Imagine the costs you have t
Imagine the costs you have 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
o pay to comply with all this. Next imagine that if you moved y
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ur company offshore you could eliminate 75% of that nussiance,
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
pay lower taxes and increase profits?
Would you choose to offs
Would you choose to offs
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ore? Well that is exactly what the shareholders want; increased
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
profits, quarterly increases and increased valuation because o
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
f it right? Indeed, now you are beginning to understand why the
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
off-shoring and outsourcing is occurring.
Next consider that y
Next consider that y
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ou foreign competitors who sell in the USA no longer have an ad
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
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
antage over you in the market place, because now you too are a
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
foreign corporation or a division of one. After all this you al
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
so see you have much lower labor costs, no Union demands and yo
.
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
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
can still sell to the US Middle Class? Wow, bonus indeed, so w
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
hy on Earth wouldn’t you outsource? Hmmm? 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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