Advice You - Business

Many government regulators believe that no industry can police itself and yet having been

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

involved in a franchising industry I see that the industry itself due to its very nature a

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

Examples of combination products may in

d structure causes cooperation between franchisees who are the investors, and the Franchis

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

rs who want to expand their brand name.

Many regulators will say they encourage us to cle

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

r our minds and consider that Franchisor is like any business will push the envelope on re

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

Combination pro

ulations in order to make higher profits. And for those folks I say to you; I am completel

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

clear, and yet cannot forget all my experiences, observations and listening to franchisee

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

, lawyers, government regulators telling me what I was seeing was not real and therefore I

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

am very slow to judge a franchisor.

You see, if a franchisor screws up then outlets fail

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

nd they go out of business. With fewer laws they have a better chance of making it and if

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

hey don't then they go out of business faster with nothing to hide behind, free-markets so

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

Following aspects would a

ve problems and bureaucracy makes them. And on the other hand I think I have seen my share

dd to the challenges in developing combination products:

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

problems in franchising such as the Decorating Den, Krispy Kremes, Boston Market, Schlotzk

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

's Deli BK, Jiffy Lube crumble, 7-11 sold to Toyko Master franchise, etc.

Still, many of

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

he companies, which had pushed the envelope on ethics and it up in last place in the franc

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

ising community and in their competitive industries. Where as those corporations and Fran

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

Professional from academic institutions, pharmaceutical industries, health care indust

hisor's which were more ethical and it up on top in the long run. There is an inherent go

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

d in franchising, which promotes honesty and integrity like no other industry. Unfortunat

.

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

ly the government regulators do not understand this fact and this is what causes increased

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

Companies that provide selfless information through particip

and unnecessary over regulation in the franchising industry. Please 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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