Answers - Legal

Well you hear it all the time on TV on shows like Lou Dobbs. They complain about outsourcing, off-shoring and job

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

losses. That big corporations are leaving the country and small businesses are getting hammered. But seldom does 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

nyone address the real causes of all this. It is not the corporations fault that they need to find more efficient

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

methods or ways around the bureaucracy, it is rather the bureaucracy itself you see.

The Government Regulatory bo

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

dies in Washington DC, do not have a clue as to how this country works and they cut down more trees than a Comet h

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

Combination pro

itting the Earth might take out. So, it is interesting all these socialist leaning folks who demand more rules, la

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

ws and regulations causing more trees to be made into forms and paperwork. And in the end what does all this burea

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

ucracy do? It simply puts up barriers to entry and makes big companies weak because they use lobbyists so they do

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

not have to compete in free-markets legitimately.

How many times has the FDA gone after the vitamin industry beca

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

use Big Pharma wanted those markets? How many times has the FCC interceded in the past to protect large communicat

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

on companies? How about the FAA going after Howard Hughes. I can do this all day. I can cite hundreds of examples

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

Following aspects would a

and never run out of material, something is rotten in Denmark and it did not start in Amsterdam with commerce, cur

dd to the challenges in developing combination products:

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

rency, loans or trade.

The problem is the bureaucracy and until it right sizes, this nation is on a collision cou

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

rse for the inside track position as China and India run right the heck over us. We either get with the program or

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

we are history; a footnote in the annals of history if you will which might read something like this;

"The Unite

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

d States of America; a great human civilization which once was, very fast rise lasting about 200 until its height

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

Professional from academic institutions, pharmaceutical industries, health care indust

with a slow decline, until it was no more."

Just between you and me, we can do better than that, and attacking ou

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

r Corporations, Entrepreneurs and such will not be the right way to fix it. And to that point, corruption in gover

.

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

nment must be the first item of business. The referees of the game must come clean or the game is a sham. Then we

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

Companies that provide selfless information through particip

can have a level playing field worthy of spectators in the Coliseum. I really want you to be thinking here in 2007

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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1. Research the show carefully before you decide to exhibit. You can save yourself a lot of heartache by knowing exactly what size and type of trade show you are attending. 2. Start planning well in advance of the trade show. Poor planning can result in unexpected costs and a poor showing.

As a mom of two boys myself, I know how hard it is to go to work everyday, and still have the quality family time you desire. It is possible, but it is hard. I have been making a nice income from home, and am able to stay with my kids. I never knew this was possible, but I have been doing it for 4 months now, and am making more than I was when I was working!

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Answers - We Are Our Own Worst Enemy; Regulatory Bodies Destroying America with Bureaucracy

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