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Just Other Articles - GM Bankruptcy?
If General Motors were to file bankruptcy, it could change the world or would it? Yes a GM bankruptcy filing would
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
change the world. Right now with all the over regulation it is amazing that any company can make money these days.
; 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
guarantee such a move would change the world. It would definitely wake up the Unions and the governments over regu
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
lation on our economic engine. In fact sometimes it seems we do everything to hold down our economy from screaming
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
orward.
With all the over regulations in this country to start, grow and run a successful small business, medium s
With all the over regulations in this country to start, grow and run a successful small business, medium s
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ize corporation or a multi-national conglomerate based in the US. Why do we attack and use regulations to slow down
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
our economic might? Because folks it is the way it is deliberately set up. You see at every level we have placed ru
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
les and bureaucracy to slow ourselves.
The largest corporations in the World are constantly being bombarded by rul
The largest corporations in the World are constantly being bombarded by rul
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s and regulations put in place by regulators and politicians. So they are forced to move the operations out of the
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
country to reduce costs, raise prices and pay off all the politicians you can find, no matter what side, fund them,
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
as you will need them just to do business in this nation.
It is interesting the talk now after the 3rd quarter los
It is interesting the talk now after the 3rd quarter los
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
s at General Motors and how they may sell off GMAC. Right now with the housing boom getting ready to pull back and
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
ome over extended upside down foreclosures due to job losses in the downturn of the business cycle, that might not
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
be a bad idea actually. It seems GMAC is going to have its own issues.
The Delphi Bankruptcy deal is a problem ind
The Delphi Bankruptcy deal is a problem ind
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
ed, I too worry about the under funded pension costs and these out of control health care costs, as for a company l
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
ike GM these are problematic issues to say the least. It is good that the Union has been cutting a little slack at
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
M these days. Ford is next and lay offs there will be big indeed.
Indeed a bankruptcy at GM would change the world
Indeed a bankruptcy at GM would change the world
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
, but why do we need such a strong signal as a wake up call when it is obvious that we need to fix the problems tha
.
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
are right their in front of us. We all should be thinking here, as all of this effects us one way or another and C
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
hina is not getting any smaller so we better get on the stick and take care of business in real time. Think on this
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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