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Advice You - The Rogue Franchisee and the Similarities to Guerilla Government Political Fights
In the world of franchising often there are rogue franchisees which
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
do not want to follow the system or the standards of the confident
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
al operations manual. This is unfortunate because the franchising
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ystem gains strength when there is consistency and quality controls
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
within the system.
A rogue franchisee who will not follow the syst
A rogue franchisee who will not follow the syst
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
m may purposely disrupt the system and therefore hurt the franchise
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
system. In doing so inevitably it is a self-fulfilling prophecy.
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
ecause the rogue franchisee often complains about the franchisor or
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
the overall franchise system and then sets out to make it fail.
Un
Un
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
ortunately, a rogue franchisee within the system can hurt the syste
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
a lot more than any outside influence or competitor could. The ro
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ue franchisee can be compared to a military coup taking over a gove
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
nment. It is also very similar to guerrilla tactics used to overthr
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
w a government.
If the rogue franchisee and the other franchisees
If the rogue franchisee and the other franchisees
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ould work together in a common cause the brand name would increase
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
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
or the franchisor and all the franchisees together and everyone wou
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
d win.
Unfortunately the infighting can degrade the system and hur
Unfortunately the infighting can degrade the system and hur
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
everyone concerned. It is interesting to study such models and un
.
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
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
erstand why working together accomplishes so much more for the indi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
idual goals of all parties concerned. Please consider 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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