Main Subject - Internet and Businesses Online

Remember when the President of the United States of America foretold us of his effort

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

s and initiatives to curb SPAM in our inbox? Do you remember when the Congress and Se

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ate passed the CAN SPAM Act and the Bush Administration signed it into law?

Well wha

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

on Earth happened? Well, simply speaking SPAM increased some 3000% since the FTC or

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

Federal Trade Commission announced the War on SPAM, yet as we know all those press re

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

eases were nothing more than a sham.

It seems that the FTC cannot stop SPAM and is i

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

potent to taking out the Viagra emails. Much of the SPAM is coming from other nations

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

like Russia and China and the FTC cannot or will not stop them. If they cannot stop

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

PAM, how can we trust the FTC on anything from Identity Theft to consumer protection?

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

The fact is we can’t as they are incompetent and they are misrepresenting the truth

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

nd must be disgorged from their ill-gotten citizen taxpayer’s monies on their next ye

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ar’s budget. Total incompetence should not be allowed in our government. Just look wh

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

t these Russian Spammers are charging these days;

“From 1.000 up to 30.000 messages

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

$2.3 for one thousand; From 31.000 up to 100.000 messages - $2 for one thousand; Fro

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

m 100.000 up to 200.000 messages - $1,7 for one thousand; From 200.000 and more - $1

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

or one thousand; At the big orders essential discounts and bonuses:-)”

How can the F

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

C stop them if the prices are so low and SPAM is working on a percentage basis? We mu

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

st get the FTC off their butts to curb SPAM and to do their job. This half-butt effor

.

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

is a little unnerving and this is unacceptable. We must fire all FTC employees, take

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

away their pensions and hire a new staff there immediately. 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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