Digg It - Business

Part Two:

Ask questions, sheesh, never be afraid to ask questions.

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

Don't be intimidated by people, they had a first day in kindergarten

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

Examples of combination products may in

s well, don't let people fool you. We all have a beginning to every single

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

hing.

Compare your information with others and define your own set of stand

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

rds that you want to allow as part of your artful deal making.

Feel good ab

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

Combination pro

ut yourself. You have worked at your technique and it has cost you MONEY to

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

get to where you are. Brushes alone are quite expensive. If you don't take

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

care of them like me you are buying them constantly. Paints add up and the

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

there is the space you paint in or sculpt in. It all adds up.

The Art

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

f Negotiation, investing in yourself is you trying to get some money, an

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

energy back. Don't shortchange yourself on that. Be your own cheering sec

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

Following aspects would a

ion to give yourself some extra confidence when that gallery does come along

dd to the challenges in developing combination products:

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

Consider all the costs involved. Just because a gallery has a pre-written

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

contract and the confidence to hand it to you does not necessarily make it a

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

good deal for you.

What about shipping? Is there a trial period? That can

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

kill you right there alone. If they expect you to pay for shipping both goi

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

Professional from academic institutions, pharmaceutical industries, health care indust

g and coming and the trial is only three weeks, is that a good investment on

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

your part? How confident are you that your art will indeed sell? Don't s

.

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

ip your work anywhere until you know that. Do your homework!

Learn all you

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

Companies that provide selfless information through particip

can before signing anything on any subject right? Right!

-----------------

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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Digg It - The Art of Negotiation, Investing in ART, Investing in YOU, Its About the MONEY Honey! Part Two

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