Main Subject - Business

So often we hear about dishonesty in ethics in business and govern

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

ment. We hear of Democratic Senators and Congressmen who will not

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

Examples of combination products may in

isten to you unless you donate money to their campaigns and this g

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

es for citizens and business people alike. It is no wonder that ma

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

y business people fund political contributions.

It is also no won

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

Combination pro

er with such a system that Congressmen go beyond the call of duty

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

of listening and intervene in business activity and help one busin

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

ss over another in the competitive market place. Indeed but really

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

didn't Adam Smith warn us of such? If you own a company and want t

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

move ahead faster, just support your Senator or Congressman and h

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

ve them call up an bureaucracy or Regulatory body to disrupt your

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

Following aspects would a

competition. Sure this has been going on for 100s of years.

Prett

dd to the challenges in developing combination products:

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

sickening to think we stand for free markets and true Capitalism.

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

It works if it is allowed to work. Ayn Rand is right, Marx is wron

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

and the politics of this nation are an absurd way to run the huma

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

race. If you want your business to grow and go to the next level

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

Professional from academic institutions, pharmaceutical industries, health care indust

you have to pay to play and that means interacting with the dishon

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

sty of the Democrats in Congress and the Senate. That is just the

.

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

ay it is and there is nothing you can do about it but deal with th

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

Companies that provide selfless information through particip

scum of the Earth to protect your business. Consider 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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