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Actual - Regulatory Compliance and The Mis-Use of Law
To protect the public from what might be called run-away capitalism
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
, the United States Government has set up regulatory bodies to curb
; 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
corporate crime. Unfortunately nearly every law they make they mak
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
not to protect the American People but rather to protect one corpo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ration, industry or business group against another. How so you ask?
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Well simple and we have all heard about corporate lobbyists who h
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
lp law-makers make the laws. Of course the politicians collect buck
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 bucks from these folks in trade for making life easy for them and
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
insuring that laws are made in order to protect their interests ag
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
inst free-market competitors who do not support the politicians wit
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
h the big campaign contributions.
Does this mean that all regulato
Does this mean that all regulato
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
ry compliance is bad? Certainly not and I estimate about 15-20% act
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
ally is needed to protect the American People, the rest of the laws
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
made are not to protect the investor, consumer or public, but rath
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
er an industry, corporation or specific business interests. Does th
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
s mean regulatory bureaucracies are a complete disgrace and utter s
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
hame? Hey good question indeed, and remember you said it not me!
I
I
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
f things are so bad why do we allow this to go on? Why do we allow
.
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
he blob of bureaucracy to run-a-muck like that? Your guess is as go
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
od as mine or Adam Smith for that matter. Consider all 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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