Advice You - Business

Franchisee has a lot to do about image. Many marketers would agree that image is the single most impo

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

rtant part of branding. In the world of franchising and brand-name extension franchisors and franchi

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

Examples of combination products may in

ing companies must pay attention to details to ensure that their brand-name stands tall in the eyes o

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

f the consumer and customer.

There is probably no easier way to destroy a brand-name or image of a f

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

anchising company in a particular marketing region than to have a drunk driving accident with the com

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

Combination pro

any's name on it show up on the front page of the newspaper. It is for this reason and because I am

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

appalled by drunk drivers that I decided to do what no other franchise or has ever done in the histor

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

of franchising; I specifically addressed the drunk driving issue in our company's franchise agreemen

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

s. Below you'll find the clause that I inserted into each and every franchise agreement;

3.24.2 Dru

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

nk Driving

Franchisee agrees not to drink and drive a mobile car wash truck or drive a vehicle while

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

towing a mobile car wash unit of the Franchised Business on a public highway when Franchisee may be o

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

Following aspects would a

er the legal limit of toxicity. Franchisee also agrees not to drive their personal vehicle in the man

dd to the challenges in developing combination products:

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

ner described above. Such violation of the law resulting in the conviction of a felony or misdemeanor

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

is subject to termination of the Franchise Agreement.

- - - - - - -

Perhaps this might be something

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

you wish to address in your franchising company and you would be well advised to consult with a 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

hising attorney to see if this makes sense for your company as well. Perhaps they have a better idea

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

Professional from academic institutions, pharmaceutical industries, health care indust

of the legality of this issue. My thoughts, were not as much the legal issue as a statement of how I

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

feel as the founder of my company about drunk driving and image. There are certainly other ways to 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

ddress this issue such as a clause about moral turpitudes and your franchise attorney can better advi

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

Companies that provide selfless information through particip

e you on this issue, please consult with them, as all I am not an attorney. Do 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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