Advice You - Business

Recently a group of franchise attorneys had come across a purported

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

violation of the New York franchise rules and regulations when an un

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

Examples of combination products may in

egistered franchisor had delivered a Uniform Franchise Offering Circ

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

lar or UFOC to a New York resident, which was not in compliance with

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

FTC rules and regulations or the State of New York.

The attorneys a

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

Combination pro

nd decided that perhaps they should turn in the franchisor who made

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

he mistake. Well I have a problem with all this. Why not simplify th

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

process, educate all the new entrants and remove the barriers to en

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

ry? No we cannot do that, what would the Lawyers have to do? All thi

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 over regulation was created by lawyers, but now we can study it fo

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

a law journal?

Why not have the attorneys step away from the flick

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

Following aspects would a

ring flame's cave wall and realize that franchising is about the mar

dd to the challenges in developing combination products:

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

et place not about the lawyers. Lawyers stifle franchising and cause

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

lost opportunities to make money solving problems and supplying the

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

needs and desires of customers. And that is how I see things.

We sh

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

uld not allow franchise attorneys to become the police, the jury and

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

Professional from academic institutions, pharmaceutical industries, health care indust

still hold themselves out to be above the law after they have hijack

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

ed the franchise laws of our nation. It is unfortunate that attorne

.

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

s continually elevate themselves and promote themselves to greater a

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

Companies that provide selfless information through particip

d greater authority in our civilization while they are destroying it

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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Advice You - Should We Allow Franchise Attorneys to Police the Franchising Industry?

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