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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

Clinton averages $150,000 per speaking engagement.

It all comes down to decisions on the fl

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

Examples of combination products may in

, no pun intended.

What you may not even think is an important decision at the time, could

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

ring down your company or your employers, in less time than it takes to say to the massage p

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

rlor attendant, “Do you take Amex?”

Does it seem like the world has gone to hell in a hand

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

Combination pro

asket overnight?

With CEO’s signing off on corporate governance, government intervention, c

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

onsumer watchdog groups, senior lobbyists, and teenagers with 24-hour Internet connections,

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

ou would think that we would be free of Corporate Disease by now.

Wrong!

As long as there

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

re decisions to be made by human beings, there will always be a select few that aren’t even

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

ware they are carriers of a communicable corporate disease.

All it takes these days is one

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

rip to the doctor, slash forensic accountant, and you have a full-scale investigation on you

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

Following aspects would a

r hands.

So what is the solution?

In short, there is only one logical solution.

Communica

dd to the challenges in developing combination products:

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

le corporate diseases will cease to exist when business people stop having unprotected corpo

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

ate relations, with themselves and other partners.

What does that mean?

It means the only

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

ay to protect you or your employer is to ensure you are wearing your corporate condom before

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

you go out and play.

No different than sex folks.

Know your self intimately, know your par

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

Professional from academic institutions, pharmaceutical industries, health care indust

tner, get tested, do a background check, ask for references, sign a prenuptial, and then whe

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

you think you have done enough…do it all over again.

Maybe, just maybe, you will stay free

.

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

of any corporate communicable diseases.

by Lee Raito, CFP, FMA
Co-Author of Business S

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

Companies that provide selfless information through particip

xcess
www.BusinessSexcess.com

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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