Advice You - Business

If you are considering entering a close niche sub-sector industry then y

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

ou will also hear rumors in the industry, some true and others coming fr

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

Examples of combination products may in

om those who have an axe to grind. It is extremely wise to listen, but n

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

ot comment. Just say oh really like you are shocked and interested. Then

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

they will tell you more of course. Still try not to judge as you will b

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

Combination pro

e listening to only one side of the story.

You might hear such things a

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

s: I believe the President of XYZ Company is a spoiled little rich kid w

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

ith a small man syndrome; I do not like him. His father God Rest His Sou

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

l, was a decent and honest gentleman. I would never personally do busine

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

ss with him. I think he is a liar and scum. This is my personal opinion

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

only. His handshake stunk, his eyes were shifty and I saw no real person

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

Following aspects would a

al character there. Call me old fashion, but I would not do business wit

dd to the challenges in developing combination products:

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

h the President of Iran either. I think XYZ Company is acting arrogant b

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

ecause they have done some test locations for Arthur Midland Daniels and

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

Monsanto. I thought the big boys were smarter than that? But last liar

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

seems to win in the sales game?

I can tell you this stuff goes on all t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he time in the agricultural industrial sector, with manufacturers, equip

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

ment providers and the entire industry. Be wise and do not make comments

.

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

, just listen. This is the best for all concerned and you will be smart

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

Companies that provide selfless information through particip

to understand this and follow such advice. So, 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 - Industrial and Agricultural Industry Warnings for New Entrants

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