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The next time I hear some congress person or some senator or some loud mouth talk radio moron express outrage about the 12,000,000 undocumented/illegal aliens we have in this country, I think I’ll shove a red hot poker in my eye or pu

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

sh a cattle prod through my ears. It would give me something more important to focus on, rather than the idiotic babble that creases my brow and knots my neck. These knuckleheads act as if the immigrant laborers arrived suddenly under

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

Examples of combination products may in

the cloak of night. It’s like that joke by heavyweight comedian Louie Anderson about being grotesquely fat, “do you think I woke up one day, walked by a mirror and in shock asked, ‘Oh! When did that happen?’”.

For decades, through al

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

l combinations of Washington political power, this blister of cheap labor has festered. The same people doing the high octane complaining now, along with yours truly, all had a piece in this action. If you had a house built, if you ha

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

your lawn cut, if you had your home cleaned, if you had your car washed, if you had your hair washed, if you ate a breakfast, lunch or dinner at a restaurant, if you bought vegetables or fruits or cheeses or milk from a grocery store

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

Combination pro

if you had a nanny for your darlings, if you participated in any of these without regard to whoever provided the labor then you have given cause in part for these immigrants.

You knew it. I knew it. Now we really know it.

And today

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

the troubled troubadours of outrage want to call them all law breakers. They exclaim, “I’m not against immigrants. I’m against illegal immigrants.” Well were they against illegal immigrants when their new house was roofed? Were they

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

gainst illegal immigrants when their restaurant table was cleared of plates? Are they against illegal immigrants every time they saut? onions? Are they against illegal immigrants when their hotel rooms are cleaned up? If they are so a

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

gainst illegal immigrants, why don’t they boycott all those businesses and purge themselves of those services that are a part of the economic machine that creates the jobs and illegal wages that entice folks from neighboring poor coun

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

ries to risk everything to do better for their families while maintaining cheaper services and goods for the savvy American consumer. But in the unlikelihood these empty headed complainers will give up their free market ways, I have a

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

better idea: shut up!

We knowingly fed this 12,000,000 pound elephant for years, and now the usual suspects are shocked at the size of the poop. The arrogance and shallowness of their words leave me shaking my head. I can only surmis

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

Following aspects would a

e that somewhere along the way each of these poor saps obtained a head injury, possibly atrophying the portion of the brain used for thinking while enlarging the portion used for speech.

Do we have problems? We sure do. In a post 9/1

dd to the challenges in developing combination products:

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

America, our borders need to be secured, something that should be done already. In fact, it sounds like a great job for the “National Guard”, if they weren’t holed up in Iraq birthing democracy or taking it to the terrorists or babys

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

itting a civil war or whatever the reason de jour is. In addition to disrupting terrorist movement, tighter border security will put a temporary lid on the labor migration, buying us time to figure out what to do with those undocument

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

d workers already here; you know, the 12,000,000.

I almost never agree with the President, but he has it right on this, as does the McCain Kennedy Bill he supports. It seems reasonable to document those here and offer some kind of as

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

imilation plan. “How” to document and “how” to assimilate is no easy proposition and will take some creative, imaginative thinking, which, given our current band of political brothers, is almost non-existant. As far as those numskulls

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

Professional from academic institutions, pharmaceutical industries, health care indust

who want to yell “No Amnesty”, again, shut up; you are complicit in this mess. You want “no amnesty”? How about “no amnesty” to businesses who continue to pay illegal low wages to their workers? We need to move the lowest wages to a

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

evel where the poorest Americans can compete for jobs. If this means increasing the minimum wage, do it. I know that translates into higher prices for houses, food, and services. So be it. To not do it avoids fixing the underlying ine

.

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

quity which feeds the revolving door of workers from poorer nations who come here, earn dollars and return home where the dollars go a lot further.

With a system as broken as this, what did we expect?

The party is over. It’s time to

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

Companies that provide selfless information through particip

ante up and pay the piper for decades of looking the other way. And anyone who wraps the flag around “feel good” illegal alien rhetoric needs to take a look in the mirror. Ask Louie Anderson, we didn’t gain 12,000,000 pounds overnight

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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Accountants are amongst the most talented people either working for or providing services to businesses. They have huge potential yet so often never fully exploit it. Why is that?

Recruiting in the 21st century is different and there are a new set of rules that organizations must follow if they are going to prosper in the years to come. Understanding what motivates a top performer to look at a new career opportunity is the key to enticing them with your proposal.

We have seen or heard of some of the most brilliant as well as the most outrageous things in our lifetime. Some of them turn out to real dampeners in the name of innovation while some go on to become the ultimate show-stoppers. The idea, of course is always to appeal to the masses in the best way possible, and creativity is the safest bet in achieving the desired goal. Mobile phone manufacturers understand this issue too well to frequently tinker with their creative impulses and stay active in a fierce competition between each other.

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Answers - 12,000,000 Illegal Aliens! When Did That Happen?

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