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Top Articles - Charades in Congress - It's Not About Immigration Folks
We're being overrun by illegal immigrants! Just listen to any talk show host, TV or radio, read any of the dying newspapers in town or pick up Time or Newsweek. Right? I mean it’s all over and they’re right except about
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
the cause and the solution
Read the headlines, the Republicans are going to save the day, the Dem's of course have our best interests at heart and I even heard one moron in Congress say they’d already made great strid
Read the headlines, the Republicans are going to save the day, the Dem's of course have our best interests at heart and I even heard one moron in Congress say they’d already made great strid
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
s because they passed the 'fence' deal awhile back. That fence will be about as effective as the electronic barrier McNamara and his Whiz Kids spent a fortune on at the DMZ in Nam. But even if it did work, Congress stil
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
hasn’t provided any funding.
Now don’t get me wrong, immigration in this country is a major problem, its costing us billions. But look at what’s behind immigration. The people from Mexico come here for a reason ... WO
Now don’t get me wrong, immigration in this country is a major problem, its costing us billions. But look at what’s behind immigration. The people from Mexico come here for a reason ... WO
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
K. If we didn’t have work they wouldn’t come. Why do we have work? We have work because our own people in this country are too lazy. We have it too good. We won’t do dirty work any more. That is the bottom line as to 'w
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
y' they come. They come because of the American dream that we’re living.
A good friend of mine lives in Texas. He moved their a few years back for warmer weather and started a construction business. He was in business
A good friend of mine lives in Texas. He moved their a few years back for warmer weather and started a construction business. He was in business
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
efore but this time he committed to starting over and hiring American' workers. That lasted exactly three months and he said, "Ed, if I'd have stuck to that strategy I'd have been broke in another three months." I hired
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
all Americans and they showed up drunk, late or not at all. My turnover was nearly every two weeks. They were lazy bums and I was going broke.
Before you think this guy might not know what he was doing, he’d been in th
Before you think this guy might not know what he was doing, he’d been in th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
business before for twenty years. He knew how to hire. He used the free market. He hired immigrants, mostly illegal. Some have been with him now for years. Guess what? They work too. His business is quite successful.
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
hat’s why they’re here, to work. But that's not the real news; the real news is the second part of the immigration issue. Why does the government take years to process the applications, which his workers have filed? Bec
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
use the government doesn’t want to solve the problem. There's too much money in it. They’re playing charades.
Check this out. A couple of months ago one of his workers gets picked up in a 'sweep' by county law enforcem
Check this out. A couple of months ago one of his workers gets picked up in a 'sweep' by county law enforcem
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ent. You see they sit back and every few months get illegal’s shopping the local Wal-Mart and cart them off to jail. His guy seems didn’t have a work visa. Now keep in mind the guy didn’t have a visa, but he did have a
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ake passport and drivers license that my friend said he could tell by looking at them they were fake.
My friend gets the usual call, said it happens every few months, and goes down and bails him out. My friend pays his
My friend gets the usual call, said it happens every few months, and goes down and bails him out. My friend pays his
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
$1,000.00 fine and off they go, back to work. That's the end of it folks, until the next sweep. It goes into the county cash flow. They didn’t deport him; get him for fake documents or anything. Of course my friends hap
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
y, because he is out of business if they do, no American's to work.
But it gets better. A guy who works for him and manages his operation, an illegal, did get deported one day. Now keep in mind they’re like twelve hour
But it gets better. A guy who works for him and manages his operation, an illegal, did get deported one day. Now keep in mind they’re like twelve hour
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
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
from the border. The guy got sent back to Mexico and was back to work in 48 hours. Efficient! It’s about the money folks. Congress is only interested because the media keeps raising the issue because it sells stuff and
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
it’s an election year.
My friend says the illegal’s laugh when they talk about the border fence or the $5,000 charge Congress is talking about imposing on them to become ‘legal’. You see the price to cross the border i
My friend says the illegal’s laugh when they talk about the border fence or the $5,000 charge Congress is talking about imposing on them to become ‘legal’. You see the price to cross the border i
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
around $3,000.00 a pop, so if we charge them five grand for a permanent fix, well, it's a cost savings. Congress is playing charades.
Let those Bozo’s know you know. Yea we need to fix immigration and get the off the
Let those Bozo’s know you know. Yea we need to fix immigration and get the off 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
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
ayroll. This issue isn’t anymore about immigration than the war in Iraq is about, well, who knows what? It’s about money. Congress costs us a fortune just talking about immigration. Follow the money and you get to the r
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ot of the problem. The money is a sad trail that leads straight to Washington. It’s amazing that an ordinary, know nothing citizen like me can find this out and Anderson Cooper and his kind report the charade.
Ed Kugle
Ed Kugle
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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