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A franchisor must insure that each franchised outlet maintains the equipmen

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

t used in the business operation. To make sure that the services and produ

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

Examples of combination products may in

cts maintain consistency and quality the equipment must also be in top notc

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

ed working order.

In our franchise agreement we decided to add a clause, w

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

hich addressed this very issue. You see, I believe that not only is this im

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

Combination pro

ortant enough to have in the confidential operations manual, I believe it i

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

s sold vitally important to the operation of the franchised business that i

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

t must be addressed in the initial franchise agreement, before the commence

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

ent of the franchised business. Below is the clause.

3.18.2 Maintenance of

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

Required Equipment

Maintenance and repair of Franchisee’s car wash truck/

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

nit(s), washing equipment, credit card machine, car phone, pager, fax machi

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

Following aspects would a

ne and computer system are Franchisee’s sole responsibility. Franchisee agr

dd to the challenges in developing combination products:

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

ees to keep all tangible items used in the Franchised Business in excellent

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

repair or fix any item, which is worn, breaks, becomes obsolete or mechanic

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

ally impaired. All items replaced or repaired shall be done so with strict

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

ccordance to the standards, specifications and procedures outlines in the l

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

Professional from academic institutions, pharmaceutical industries, health care indust

oaned copy of the Confidential Operations Manual.

--- --- --- --- --- ---

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

--- --- ---

Since I am not an attorney, you may wish to contact the franch

.

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

se attorney and ask them if such a clause in your franchise agreement makes

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

Companies that provide selfless information through particip

sense for your franchising company. I hope you will 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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