Advice You - Business

Community Goodwill must be maintained thru proactive public rel

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

ations programs in the cities and towns where Universities are

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

Examples of combination products may in

located. Due to this reason it makes sense for Universities to

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

participate in Neighborhood Mobile Watch Programs. Why you ask

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

? Well simple really consider these points;

UNIVERSITIES: Univ

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

Combination pro

ersities have their own campus police, as well as their own set

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

of problems. They are well aware of what happens on campus and

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

are willing to participate to mitigate any negative PR that ma

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

y have occurred in the past at their school. It shows they are

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

doing something very proactive and also helps nearby residence

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

feel safer. Universities should welcome this program and even w

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

Following aspects would a

ish to modify it to fit their needs on campus. Great, let them,

dd to the challenges in developing combination products:

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

it is about working together, not who thought of the idea or w

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

ho gets credit for it. Our job is to prevent crime, make people

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

responsible and to fix the problems.

Any time we can create s

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

ynergies in pre-existing systems and network them together for

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

Professional from academic institutions, pharmaceutical industries, health care indust

the common good everyone is all the better for it and it become

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

s the most fair for all concerned. Indeed the University can ge

.

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

nerate on-going goodwill thru their participation and a huge bi

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

Companies that provide selfless information through particip

te out of crime can be taken. 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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