Summary - News and Society

Some say that civil servant workers are just taking up space and wasting taxpayer’s money. Some say tha

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

t while civil servants may think they are helping they are not. They will say that civil servants are m

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

Examples of combination products may in

rely debris in the way and they are part of the blob of bureaucracy and destroy the forward progress of

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

mankind.

Let’s say that civil servants are like most average Americans with one-third dishonest, one-t

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

ird honest when it is convenient and one-third trust worthy? That means that civil servants in governme

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

Combination pro

t are 33% criminals, 33% would lie or cheat for a $10.00 stipend and as for 33% who are those good folk

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

in government, well some might say that they are sponging off our taxpayer dollars.

Many may disagree

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

on the absolute complete disregard some government workers may or may not have or for the barriers cau

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

ed by the blob of bureaucracy on our personal freedoms. Others believe that cutting 85% of all governme

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

t agencies needs to be done to curb waste and clean house. Perhaps more civil servants could become sel

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

-employed so they can see the reasons for all this animosity. Then perhaps we might watch them as they

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

Following aspects would a

attle the blob of bureaucracy, until they see the whole truth. You see if you have this conversation wi

dd to the challenges in developing combination products:

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

h a civil servant they do not know why you are upset. They tell of their faithful service showing up on

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

time every day. But they do not see the other side of things.

If these civil servants and what some ca

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

ll paper pushers joined the ranks of the entrepreneurs then we would watch as they pulled favors to get

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

ahead from their old buddies and friends in government. Eventually they would get frustrated and find o

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

Professional from academic institutions, pharmaceutical industries, health care indust

t that the system is screwed up. Adam Smith would laugh his BUTT off over my offer to help government w

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

rkers with free information on my industry to help them start their own businesses, as the government w

.

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

rkers who take me up on it fall on theirs. As government cuts costs and jobs and these fine folks in go

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

Companies that provide selfless information through particip

ernment attempt to start their own small businesses, well, it will be interesting to watch 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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