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Recently a gentlemen emailed me to tell me that among other things outso

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

urcing was destroying America and that Bill Gates was the devil. It is i

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

Examples of combination products may in

teresting that someone of this inability to understand reality is not re

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

lly worthy of arguing with, yet his persistence in such bogus notions is

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

fascinating indeed.

In the last few years before my retirement even bef

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

Combination pro

re unemployment peaked at an all-time historic national low; I could not

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

find workers willing to work hard or diligently for any amount of pay. 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

o many were on drugs or had lackadaisical attitudes towards work, show u

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

when they felt like it, do half ass work and then demand more and more.

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

As an employer, it was obvious to me that these people do not care to wo

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

k, have a job or participate in anyway in the productivity of the compan

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

Following aspects would a

y. You see it is all about them and not the team. So, remind me why I sh

dd to the challenges in developing combination products:

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

uld keep jobs in the country and beat my head against the wall with all

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

his name-calling? Hmm?

The fact is that Jason represents a growing numb

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

r of Americans who are disenchanted with the available work. Although ar

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

unwilling to realize what caused it in the first place. Even worse is f

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

Professional from academic institutions, pharmaceutical industries, health care indust

lks like Jason are of weak minds and are merely repeating what they hear

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

on the TV set as their basis for an argument. It is silly to bother wit

.

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

such things really although I thought you should know. Do not be so gul

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

Companies that provide selfless information through particip

ible like Jason is, it will serve no one any good. Consider 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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Quick! Can you find your homeowner’s insurance policy? How about that warranty you bought for your television last year? Would you know where to begin looking to find your child’s birth certificate?

Promotional products everyone uses them. Once every body thought of them as gadgets, today there use is a matter of a company's survival.

The field of investigative reporting involves bringing to the fore facts and figure that affect human interests and fair governance. This means conducting in depth research, looking at public records, doing extensive interviews, as well as checking and rechecking of facts before publication.

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