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Top Articles - Corporate Fraud; We Need More Regulation to Make More Criminals!
Not long ago a Harvard Law professor who admitted on the Sean Hanity Show said that he was
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
indeed a liberal and that point was out of the way in the first question. The Harvard Law
; 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
Professor stated that Corporate Fraud was out of control and that we needed more regulatio
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
n in the United States to prevent it.
I found this ironic as much of the Corporate Fraud
I found this ironic as much of the Corporate Fraud
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
omes from Harvard Graduates and they are able to get away with it because of the Harvard 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
awyers they hire, which often have worked in government themselves or volunteered for comm
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
ttees in the regulatory bodies; incestuous revolving door.
Of course now there are so man
Of course now there are so man
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
y regulations on business that we prevent new innovations from coming to market and make i
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
more enticing for corporations to off-shore or out source over seas. This is not helping
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
America. Additionally, each time we make a new rule or regulation we also create more corp
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rate criminals.
The faculty member in discussion is indeed incorrect in his comments and
The faculty member in discussion is indeed incorrect in his comments and
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
we must be so careful not to intervene unless totally necessary, we must resist. As Alan G
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
eenspan recently told the US Senate when discussing rule making and regulations on indepen
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
dent brokers in relation to the SEC;
“The problem when making rules is that once you make
“The problem when making rules is that once you make
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
one, it has a life of its own and the temptation to make another to shore up the first is
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
too great and on and on it goes”
I would propose a “red magic marker” committee to go thr
I would propose a “red magic marker” committee to go thr
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
the health care industry regs. Then an increase in oversight on personal injury and malpr
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
actice lawyers. Thinking out loud here.
I certainly hope this article is of interest and
I certainly hope this article is of interest and
.
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
hat is has propelled thought. The goal is simple; to help you in your quest to be the best
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
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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