Advice You - Business

As the founder of a franchising company I often looked towards international markets to exp

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

and our brand name and our company. Of course now with all the political tension in the wo

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

Examples of combination products may in

ld in the Middle East and in Central and South America one has to wonder if that is a safe

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

et. If you put in company-owned units in South America or Central America who is to say tha

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

in the future the government will not come and confiscate the business.

We know from hist

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

Combination pro

ory that when nations turn to socialism or communism that the first thing they want to do t

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

equal the playing field between rich and poor is to take away assets from the rich. A for

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

ign business entity in their country might be the very first target.

For instance if we lo

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

k at Venezuela and Bolivia we see this has occurred in the last year. Venezuela took over 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

he phone company and several other large businesses some of them were US-based and Bolivia

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

ook over the private industry mining operations and of course they broke the cardinal rule

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

Following aspects would a

f free markets, but they were able to justify it to the people; so much for economic stabil

dd to the challenges in developing combination products:

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

ty and international banking and monetary flows.

Companies like McDonald's always have to

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

worry when a country's population is upset at the United States of America. Often the symb

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

l of McDonald's to the rioters is the same as the Western world or United States of America

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

This can be extremely problematic and franchising companies in the future are going to ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

e to be very careful as they expanded to foreign markets.

They must consider the eventual

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

potentiality of their property being seized. I certainly hope this article is of interest a

.

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

d that is has propelled thought. The goal is simple, to help you in your quest to be the be

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

Companies that provide selfless information through particip

t in 2007. I thank you for reading my many articles on diverse subjects, which interest you

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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