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Rule of Thumb for exporting technology. The American People need piece of mind to get this economy moving. We should never export anything, w

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

hich can be used as a weapon against the American people or our close allies, which we in fact cannot defeat quickly and effortlessly. Such a

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

Examples of combination products may in

F-16’s with electronic warfare components, Phoenix Missile Systems, Smart Bombs, UAVs, Small Pox Viruses. (Yep Ft. Detrich, want to read a s

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

ary book? Try Cobra Event and Hot Spot and the new one The Demon in the Freezer).

There is no excuse to give away technology or viruses, whi

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

h can be combined with other technologies to produce weapons of mass destructions. WMDs are too common already and we cannot assume that toda

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

Combination pro

an ally will be a foe tomorrow. You guys ought to be up on this stuff and need not wait until you are warned by fiction writers such as Rich

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

rd Preston, Tom Clancy or others to get you act in gear. Why is it that this careless stuff is happening? You have foreign scientists going t

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

rough the annals of the Library of Congress, reading 1000’s of pages a day from the PTO and we allow exports of technology to literally 155 c

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

untries? Who on Earth is watching these things. We get mad a Boeing and other component manufacturers for selling aluminum tubing and then in

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

Washington freely respond to inquiries which are not verified? What is going on? Half of Washington D.C. is afraid of an attack meanwhile “th

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

se fine people in government” put us at risk?

Please spare me the Yellow, red, pink, color pastel finger paints. With the extra money we are

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

Following aspects would a

spending to fight terrorism we are coming up with some dandy technologies which will spill into the private sector and create jobs, security,

dd to the challenges in developing combination products:

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

increased quality of life, efficiency for profits and so many benefits for mankind, yet those technologies used for DARPA’s next wave, should

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

be lock and key baby. No way in, no way out. As technology gets smaller it will be harder to detect and easier to conceal, and even more pote

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

t with the right enemy. We must slow the flow of technologies to potential adversaries and increase our forward momentum of offensive efforts

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

to seek out and kill the enemy and make examples of them so others in those countries do not come calling. Shoulder launched SAM technologies

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

Professional from academic institutions, pharmaceutical industries, health care indust

RF Bullet devises, etc, cannot fall into enemy hands until we have technologies to defeat them.

There are hundreds of technologies that we

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

re developing now that are very efficient to defend our population, but without counter measures, we could get into trouble. Pay attention pe

.

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

ple. Half way is no way to run this country. If you are serious about the safety of the American People, then how come that message has not p

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

Companies that provide selfless information through particip

rmeated the staffers and fine folks in government at the lower levels? Just some thoughts on this safety game, color scheme and reality check

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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Life is full of uncertainty. Cropping up of a financial insufficiency and money seems to be coming of nowhere can crash up your cool and calm life. And what if in such situation your home assists you. Yes, the home you built to save you from the sunny day can also be your umbrella for a rainy day.

Please don't let the one person who should be held accountable for this huge mess have the chance again to make it even bigger. Mr. Secretary Robert Gates you are the perfect man to pull us out of this huge mess.

Thoughts and ideas expressed in a dialogue, questioning the motives and effects of an Affirmative Action policy.

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