Advice You - Business

To maintain the consistency and image of a franchising system, even a mobi

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

le-based franchise, each franchisee must maintain standards of signage. T

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

Examples of combination products may in

is issue will be addressed generally in the confidential operations manual

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

set forth by the franchisor. However, I found it necessary in my franchis

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

ng companies to go one step further, I inserted a clause into our franchis

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

Combination pro

e agreements stating such. Below please find a clause I inserted into eac

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

and every one of our franchisees franchise agreements;

3.22 Signage

Fra

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

chisee must maintain and display standard signs on Franchisee’s car wash t

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

uck/unit(s) in accordance with the specifications established by Franchiso

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

r and outlined in the Confidential Operations Manual.

All signs on the ca

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

wash truck or trailer unit must conform to our sign criteria as to type,

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

Following aspects would a

olor, size, design and location. All signs must be approved in writing by

dd to the challenges in developing combination products:

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

ranchisor prior to installation or display if they do not conform to the C

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

onfidential Operations Manual.

- - - - - -

All franchising companies mus

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

address the signage issue. In location based franchisees such as retail

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

utlets it is a much more serious issue, but all too often simplistic home

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

Professional from academic institutions, pharmaceutical industries, health care indust

ased or mobile franchise companies do not address this matter properly. I

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

would recommend that you seek the professional legal counsel of a franchis

.

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

ng attorney who is knowledgeable inexperienced so that you might address t

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

Companies that provide selfless information through particip

is issue properly if you run a franchising company. 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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