Advice You - Business

Franchisor who sell franchises must be very careful to make sure tha

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 the person inquiring about franchise offer is indeed from the stat

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

Examples of combination products may in

e of residence that they declare on the franchise application forms.

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

Other wise it is quite possible that you as a franchisor could be in

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

violation of offering a franchise to a resident of a state in which

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

Combination pro

you are not registered in.

Often franchise prospects do not make 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

clear their state of residence. I have had franchise buyers sunning

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

in Palm Desert, come to find out they only live their half year and

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

reside in ND. We did not register there, many franchisors never do

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 technically that would be a violation of North Dakota franchise l

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

aw. Although this may sound somewhat irrelevant and probably would n

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

Following aspects would a

ot get anyone in any trouble because it was the prospective franchis

dd to the challenges in developing combination products:

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

es fault, it could cause future legal issues and conflicts.

Worse o

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

ff some franchise attorney reviewing the documents might make an iss

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

ue of it and turn you into the North Dakota State. Big deal, but it

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

ill mean you end up on their bad guy list if in the future you ever

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

Professional from academic institutions, pharmaceutical industries, health care indust

do decide to register in that over regulated petty political state s

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

omeday? It is indeed pure insanity that ND would have special 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 laws, as it is such a small state it is not economically worth mo

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

Companies that provide selfless information through particip

st Corporations time to do business there. 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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