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Apparently diplomacy is not working with Iran and they are continuing to enrich uranium to

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

make nuclear weapons and they continually sponsor international terrorism. This is very

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

Examples of combination products may in

roblematic for Western world civilization and one has to wonder if we are seeing a repeat

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

of the North Korean crisis.

As you may recall North Korea promised that it was enriching

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

lutonium only to make power for itself. Then it detonated in early October of 2006, an un

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

Combination pro

erground nuclear weapon. Luckily it was all underground and it appeared that no radiation

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

had gotten out to cause fallout. North Korea promised after the test that their nuclear w

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

apons were only for deterrent in case of US invasion. This of course is political rhetori

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

c for the mass world media.

The six party talks and diplomacy did not work with North Kor

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

a and it appears that we are seeing a repeat of past failures of the international communi

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

y similar to the Iranian nuclear crisis showdown. The continuation of proliferation of nuc

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

Following aspects would a

lear weapons from rogue nation states is a scary thought indeed.

Additionally, since Iran

dd to the challenges in developing combination products:

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

has also met with North Korea and North Korea is interested in exporting these new weapons

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

of mass distraction, then it looks like Iran is a potential customer. This of course is

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

roblematic because Iran has promised to; Blow Israel off the Map! Also, Iran sponsors int

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

rnational terrorism to the tune of $100 million per year to groups like Hezbollah.

Obviou

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

Professional from academic institutions, pharmaceutical industries, health care indust

sly something must be done in the world community, but diplomacy is not working and there

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

ave been too many international community failures in negotiation in the last decade. The

.

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

world cannot afford to risk rogue nations with nuclear weapons. It should be obvious tha

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

Companies that provide selfless information through particip

someday a major city will get nuked if nothing is done. Please 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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