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Useful Articles - FTC Complains of Health Food Claims
The Federal Trade Commission complains that many groups make fal
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
se claims or rather unsubstantiated claims about certain health
; 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
foods, which may not do much of anything. Actually in looking at
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the total picture this is rather hilarious in that the Federal T
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
rade Commission has never once been able to prove that it has ac
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ually reduced fraud.
In fact I have never seen one scientific r
In fact I have never seen one scientific r
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
esearch paper proving that the FTC actually helps consumers, not
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
one, from any reputable University research department. I have
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ever seen any empirical proof they crime, fraud or misrepresenta
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
tion has been reduced by the FTC. This is not to say that their
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
laims are not real when they state they are helping the consumer
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
. It is to say they cannot prove it. And since they cannot prove
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
it then by their own rules, they cannot say it right? Fair is f
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
ir, let’s be honest?
Indeed I dare to ask the question is the U
Indeed I dare to ask the question is the U
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
nited States Justice Departments Federal Trade Commissions Consu
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
er Protection Division attacking and suing Health Food Companies
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
because of the claims they make that they believe to be false o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r because they have been persuaded too by politicians who have b
.
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
en paid under the table by drug company lobbyists?
That is my f
That is my f
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
inal question; no other questions your honor. Think on this 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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