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  • Advice You - Ethics and Competition in Franchising Leaves Unanswered Questions

    In most industries in the United States of America we find that there are competitors who were willing to cheat and they are very careful to cover their tracks. In fact, there are companies that s
    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
    pecialize in corporate espionage. You can find them online and learn some of their tactics and you can even books looks at the local bookstore that tell you how to do it.

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

    Examples of combination products may in
    ry, which I was involved with for nearly 2 decades we constantly had our competitors pretending to be franchise buyers so they can get a hold of our uniform franchise offering circular.

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

    m Franchise Offering Circular or UFOC is a required document that you must give to each franchise buyer 10-days prior to them buying a franchise. This disclosure document and their attachments are
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    generally 200 or more pages. And the UFOC there is more information than someone could get going through your personal laptop or through all the drawers and filing cabinets in your office.

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

    Combination pro
    n unbelievable amount of disclosure, which is required by law. This prospectus includes audited financial statements of your business, lists of all your franchisees, your future expansion plans an
    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
    d just about everything else including the color of underwear you are wearing this morning.

    Obviously your competitors will want to get a hold of this information so they can better compete with y
    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
    u. In my company we actually had someone buy a franchise and allow us to help them set up the business only to find out later that the money they used was that of a competitor.

    You see, they had n
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    o intention of running the business all they wanted is a complete set of our operations manuals, UFOC and all the inside information that our company had including the training modules. This disho
    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
    esty and lack of integrity is unbelievable.

    Later, the individual attempted to file a complaint with a state agency and a federal regulatory agency that we had misrepresented ourselves during the
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ale of the franchise. Of course this is utter BS and yet there are consumer laws that protect the consumer over the word of the Franchisor.

    In fact once a regulatory agency starts an investigatio
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    n you are guilty unless you can prove yourself innocent. It is the biggest bunch of horsesheet I have ever seen. But this is how the reality of business works and how the regulatory agencies do t
    dd to the challenges in developing combination products:

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

    If the United States of America and the regulatory agencies cannot do any better than this then we can never have free enterprise or a level playing field in any industry. This also means t
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    hat we will stifle innovation, hurt entrepreneurs and missed opportunities in the marketplace and be passed by other nations in various industry sectors and sub-sectors.

    After retirement and looki
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    g back on the situation it seems to be a game that an honest person would not like to play, nevertheless an honest business person can do a lot of good in the world, but one has to ask is it worth
    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
    t?

    If Franchisors are required to disclose at that level of information to anybody buying a franchise and it is obvious that their competitors will attempt to get that information by pretending to
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    be buyers. The government does not care and the regulatory agencies are blind to the reality of the situation.

    And in doing so they cause more harm to new franchise ores and start ups and a they
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    are really need that market sector much like they have ruined so many industries in the past. I hereby can damn the regulatory bodies of the United States of America as ignorant, incompetence and
    .

    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
    utterly worthless. And I have the facts, paperwork and proof to back up my statements, unlike the regulatory bodies or the competitors.

    What we have here is a bunch of weak human beings that cann
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    t handle competition and a lousy ignorant government to help them cheat. Who needs that? Consider this in 2006 and if you think this is too harsh, I say that is irrelevant because it is the truth


    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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