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Well what happen to the War in Spam, it has been two years an

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

d the Federal Trade Commission is over budget, asking the Uni

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

Examples of combination products may in

ted States Congress for more and still no end in site to all

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

this SPAM. The casualties in the War in SPAM may soon reach s

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

ome 2500% increase since it started. And there are now Spamme

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

Combination pro

r insurgents from neighboring nation states supporting these

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

folks.

And You have got junk mail still! But I thought I rea

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

d countless Public Relations pieces and press releases of how

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

the FTC was going to get tough and CAN SPAM, but that was an

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

embellishment, as there were no weapons of mass attack to be

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

at these spammers. Now the taxpayer is footing the bill for t

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

Following aspects would a

his war. When we could be using this money to rebuild our Hur

dd to the challenges in developing combination products:

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

ricane stricken consumers. This whole thing was not about SPA

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

M it was about revenge to take out the evil doers of the Inte

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

rnet and pump monies into the war budget of the FTC.

Why can

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

’t we trust our leadership to give us the straight goods on t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he War in SPAM? There is something dastardly conspiratorial i

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

n this whole thing and it seems the taxpayer is the one at ri

.

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

sk from these International Spammers and we are paying double

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

Companies that provide selfless information through particip

due to the inability for the FTC to execute the War in SPAM.

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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