Advice You - Business

It is amazing that State Franchise Registration State Examiners like those in the St

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

ate of Illinois Franchise Registration Examiners Office often believe they are prote

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

Examples of combination products may in

ting the investor. But really they are not because the over regulation they place on

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

Franchisors means they must raise the costs of the franchises they sell by quite a b

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

t and therefore pass that onto the consumer or investor, thus the State of Illinois

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

Combination pro

ranchise Registration Rules and their persnickety Examiners are hurting the very con

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

umer they purport to protect you see?

I think it is high time that they go read Any

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

Rand. No Regulator should EVER, be allowed in to regulate franchising until they hav

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

worked on the Franchisor side of things. Of course when I alerted the State of Illi

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

ois Franchise Registration Examiners of this fact they told me that these views of f

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

anchisors are perception based? Well, then let me educate you and your so-called "Pe

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

Following aspects would a

ception":

dd to the challenges in developing combination products:

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

rget="_blank">www.ftc.gov/os/comments/franrulestaffrpt/OL-100001.pdf

In my prof

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

ssional opinion regulators abuse laws, divert millions of dollars unnecessarily to l

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

wyers who hide the tools needed for franchisors to by-pass them. The disclosure laws

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

give away too much information to competitors and the 35% of all inquires to the fra

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

Professional from academic institutions, pharmaceutical industries, health care indust

chisor which are fake. The registrations states and FTC should be fined for Identity

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

Theft in forcing franchisors into over disclosure, which is also helps foreign compe

.

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

itors to more information than is available in the franchisors corporate office, pho

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

Companies that provide selfless information through particip

e records, trash cans (pre-shredder) and computer systems. 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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