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We often see in business when a company has to lay off thousands of people they bring in

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

someone from outside the company to do it. Then all the employees can be mad at him. On

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

Examples of combination products may in

ce all the layoffs are completed then the company will terminate him and the employees s

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

ay; See you SOB you are out of here, we run this company and we got you fired.

This hel

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

ps the remaining employees cope and feel good again about working there. I know it is a

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

Combination pro

silly strategy, but it works because no one watches the pattern in Corporate American an

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

d how this all works. Of course some Management Professors say the reason for the change

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

management after the lay offs is because without it the CEO is simply ineffective and ca

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

nnot lead as everyone is upset and no one will follow.

Nevertheless, if all these manag

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

ement professors are correct in that ridiculous excuse then why do they always bring peo

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

ple in before the layoffs and Executive Management often retires just prior? Hmm? Well,

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

Following aspects would a

now lets look at the Political Parties. Each one does basically nothing, but waste taxpa

dd to the challenges in developing combination products:

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

yers money, raise taxes or screw everything up. I am not complaining they are all humans

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

and cannot do much of anything anyway.

But don’t you find it odd that each party does

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

eally good to start because they promise change and change looks like it is happening ye

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

t we find out in the end nothing really changed? Same game just a different set of playe

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

Professional from academic institutions, pharmaceutical industries, health care indust

rs. Then elections come and the pendulum swings. Oh this time will be different and they

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

will solve all our woes? I mean do you people really buy all this malarkey? If the Demo

.

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

crats get into office this time, nothing will change? That is so silly to have faith in

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

Companies that provide selfless information through particip

an on-going disaster of what our Founding Fathers had planned. 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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