Advice You - Business

Having a good mission statement for your company is essential and

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

it really does not matter how big or small your company. Consider

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

Examples of combination products may in

it like a Constitution really. It is much about the goals and obje

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

cts, morals and integrity, as well as the link between what you do

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

in the market place with what you do internally in your organizat

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

Combination pro

ion. It needs to be a yardstick of sorts, which also clearly indic

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

ates what you consider winning and success.

Every person in the c

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

ompany, non-profit, team, unit or organization must understand the

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

ir job description and how that it applies to the groups mission s

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

tatement, if they fail to understand this then they will make a mi

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

take when they are required to think outside the box of what they

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

Following aspects would a

have been trained when the scenario does not fit the situation at

dd to the challenges in developing combination products:

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

hand.

They need to be able to readily see how their job and doing

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

it well relates to the over all mission statement, goals and obje

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

ctives of the entire team. If you fail to show them the relevance

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

then you will run into problems down the road.

Each play, job wel

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

Professional from academic institutions, pharmaceutical industries, health care indust

l done, customer, goal, battle or donation collected needs to be u

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

nderstood at every level and everyone must work together in a comm

.

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

on cause and that common cause is the mission statement. I sincere

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

Companies that provide selfless information through particip

ly hope you can appreciate this insight. 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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Advice You - Business Management and Organization; Understanding of Mission Statement

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