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The Department of Justice’s Federal Trade Commission’s Consumer Pro

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

tection Division’s CAN SPAM Act, Anti-SPAM Group had defrauded the

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

Examples of combination products may in

American People say many Anti-SPAM activists. How dare the FTC repo

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

rt to Congress of their dismal performance after their horse and po

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

ny show about their clever and aggressive fight on SPAM? Was all th

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

Combination pro

at a lie? It appears to be as their report to Congress indicated on

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

ly a 9% decline in SPAM. Many believe that in itself is a lie, I am

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

in agreement, as I too have been studying SPAM and can tell you tha

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

t that SPAM is not going down, it has not for me.

The Department o

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

f Justice’s Federal Trade Commission’s Consumer Protection Division

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

’s CAN SPAM Act, Anti-SPAM Group has failed the consumer and now fr

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

Following aspects would a

audulently misrepresents to the American People with what I believe

dd to the challenges in developing combination products:

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

to be bad data. How can we trust the Justice Department of the Uni

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

ted States of America in a time when they need the support of the A

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

erican People on the war on terror, when we have a division of a di

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

vision of a division running around doing public relations skits wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

ich are a fa?ade and farce. We must throw in jail those who are res

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

ponsible at the FTC and put in prison anyone who lied to Congress a

.

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

t the The Department of Justice’s Federal Trade Commission’s Consum

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

Companies that provide selfless information through particip

er Protection Division’s CAN SPAM Act, Anti-SPAM Group. Think on it

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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