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Top Articles - Over Regulation Killing Small Businesses and Franchising
More and more people want to own their own businesses, but government obviously does not seem to wa
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
nt that. It is rather obvious when you look at all the hoops, forms and regulations that small busi
; 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
ess folks must deal with. For instance in our company we have a mission statement, a simple busines
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s model and we franchise this with our huge demand from customers. Piece of cake right; you wish.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ut it should be that easy, as these are really simple and basic components for a good business, yet
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
you should see our latest UFOC-Uniform Franchise Offering Circular, pre-sale disclosure documents r
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
equired of all franchisors. It is 210 pages including exhibits, audits, and agreements. That is t
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
tally nuts. Think about it, we are in the mobile pressure washing business, we wash stuff right? A
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
d we make an arrangement with others to use our system, which we have all mapped out, and with the
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
right person following the program it works; yet if someone does not follow the program suddenly it
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is our fault.
So then we are forced to be autocratic, to make sure everyone follows the rules so t
So then we are forced to be autocratic, to make sure everyone follows the rules so t
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
ey do well. Otherwise they twist their story and come up with some convoluted variation on the eve
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
nts occurred and sue us? When it was actually them who did not follow the plan. Now think for a s
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
cond would the attorney representing the culprits who made up the story ever care about right and w
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
ong? No they would be filing against the entrepreneur because that is where the money is? The atto
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
rney is in business to seek relief even if the claimants are lying in the complaint. See the probl
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
m for entrepreneurs?
There is too much over regulation by bone headed bureaucrats and too many lit
There is too much over regulation by bone headed bureaucrats and too many lit
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
gious lying lawyers. If America could fix this one problem our economy would take off and stay airb
.
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
orne for a century without these bogus business cycles. Should we cull all the lawyers and lay off
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
ll the bureaucrats? Hard to say really but something needs to be done. So 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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