Advice You - Business

There are so many pitfalls for new franchisors in the market place such as required manda

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

tory disclosures, state registration rules and franchise disclosure documents. Often Fran

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

Examples of combination products may in

hising Regulatory bodies make it tough to get a hold of this information and Lawyers char

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

ge for it and charge to help you comply. Worse off some lawyers will try to turn you in t

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

state regulatory bodies if you do not properly comply with every tiny minute detail. Thi

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

Combination pro

s is really unfortunate indeed. Why you ask?

Well it just seems that there are a lot of

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

oung and naive franchisors out there and a lot of people who really really want what they

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

have to offer. And yet with the costs, mix-matched set of laws and all the rules, it mak

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

s it tough on them to get going.

Additionally if lawyers can write a letter to the NY St

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

ate Franchise Registar and get satisfaction and a normal franchisor individual cannot cal

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

their offices, then it seems that the lawyers have hijacked the law and you have to hire

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

Following aspects would a

one to talk to the NY offices in order to find out the rules you see? A disclosure docum

dd to the challenges in developing combination products:

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

nt should be a 3-4 page form is all, not 235 pages of information, with more information

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

than your competitors could ever dream of having, sold online to anyone from China who wa

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

ts it?

We need one set of laws for franchising and we need to stop acting like the Unite

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

d Countries and start acting like the United States. Franchise Lawyers are a very self-se

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

Professional from academic institutions, pharmaceutical industries, health care indust

ving group in my opinion. I think that; SELF-Serving; is the only phrase in franchising

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

that these lawyers have never attempted to define? Lawyers like to define things and anal

.

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

ze stuff, but if you do not call an ace an ace and a spade a spade then you end up arguin

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

Companies that provide selfless information through particip

g over apples and oranges when you are selling Avocadoes in the market place. Consider 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 - New Franchisors in Market Place Need to Watch Out for Lawyers

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