Main Subject - Business

When the government wishes to promote a new project or social program

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

to the American people it must be very careful to be able to clearly

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

Examples of combination products may in

and concisely explain it. The program must be based or bathed in rea

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

lity and containing a good portion of common sense. Of course the mo

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

t important thing is it must be simple and easy to understand so that

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

Combination pro

everyone can get the concept.

There must also be a secondary set of

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

facts and figures for those who wish to check out the program and see

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

if it is doable to help them better rationalize the viability of the

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

project or program. It is not easy to present a new government proje

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 to the American people because the American people are inherently s

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

spicious of new government programs, which will cost taxpayers money.

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

Following aspects would a

In fact, although most people trust the American government there a

dd to the challenges in developing combination products:

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

e a large group of folks who didst trust the government and will imme

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

diately called any new program into question because of perceived pas

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

launched programs, which were botched. You can not please all the p

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

ople all the time, but you must help the American people understand w

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

Professional from academic institutions, pharmaceutical industries, health care indust

hat it is that you are trying to do.

Additionally there should be a

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

hird set of scientific data and research to back up your program. An

.

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

d it must pass the smell test of common sense for the average citizen

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

Companies that provide selfless information through particip

as well as peer reviewed research. Please consider all 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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