Advice You - Business

In the World of Franchising every thing must be documented as the relationships could go South and t

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

urn into litigation. It has not always been this way, however due to the number of attorneys trying

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

Examples of combination products may in

to scrap the creme off the money flows in the industry it has become a constant legal game. Personal

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

ly I am more in line with Caesars thinking of what to do with all these professional parasites or La

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

wyers. [opinion].

Never the less part of the CYA documentation war in franchising has to do with no

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

Combination pro

tices and communication between franchisors and franchisees. It is for this reason that I had decide

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

d to re-write our franchise agreement to include this clause below;

7.4 Notices and Communications

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

All notices required by this Franchise Agreement will be in writing. They may be sent by internatio

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

nal air mail, certified or registered mail, postage prepaid and return receipt requested, first clas

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

s-postage prepaid return receipt requested; international overnight courier or such other means of d

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

elivery affording proof of receipt. They may be delivered personally and receipted. Notices will be

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

Following aspects would a

delivered to Franchisee at the address of the Franchised Business as set forth in this Franchise Agr

dd to the challenges in developing combination products:

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

eement, to Franchisor at our mailing address at; _____________, or to other locations specified in w

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

riting.

If Franchisee is a business entity, Franchisee must designate in writing to Franchisor the

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

name and address of its agent to receive notice. Notice to the agent will be conclusively presumed t

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

o be full and adequate notice to Franchisee. Notice shall be deemed to have been given on the date o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f actual receipt, or if delivery is refused, on the date of attempted delivery.

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

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

---------

Now then you of course will need to discuss this with your own lawyer if you are a franc

.

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

hisor, as I am not a lawyer nor would I stoop that low. It made sense for our company to consider th

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

Companies that provide selfless information through particip

is issue and address it in this way and you may find another solution, but consider all 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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