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  • Useful Advices - Large Corporate Franchise Exemption a Regulatory Scam by FTC

    It certainly could not be more obvious the incestuous relationship between big business and government
    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
    than when the FTC made a special exemption of the Franchise Law for Large Corporate Franchisors. There
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    is practically no fraud at all to be heard of in the franchising industry. Now there is quite a bit in
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    the business opportunities sector, but in franchising there is very little something like 0.1%.

    That
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    goes for both large franchisors and small franchisors. Unfortunately the Federal Trade Commission has
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    decided to exempt corporate franchisors who sell franchise outlets that cost over $1 million from the s
    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
    ame regulations that smaller franchisors have. Many large franchising companies sell franchises and pr
    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
    etty much keep all the economies of scale that are earned from their size rather than passing them on t
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    o the franchisee - yes, I know that is business right?

    Thus the franchisee is merely buying a job and
    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
    not by any business at all, so is it really a franchise outlet in that case. This is unfortunate and v
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ry unfair and the unsuspecting franchisee has no clue, worse off the large corporate franchisor exempti
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    on puts the little franchisor at a severe disadvantage. The small franchisor now has all the costs, wi
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    thout the economies of scale to compete with the larger franchisor.

    So once again the government has f
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    avored the large corporate entity over the smaller business. Why you ask? It should be fairly obvious
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    with all the lawyers and lobbyists and the incestuous relationship between federal agencies. Can you
    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
    believe the Federal Trade Commission is actually part of the United States Justice Department? It just
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    blows me away. And they do this out in broad daylight and they have these rule-making sessions and ev
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    erybody just smiles as if it's OK.

    What a complete sham in my opinion - it is a scam is then perpetuat
    .

    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
    ed by the Federal Trade Commission. This article is my opinion and I'm sticking to it because I am an
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    observer and I closely watch the hypocrisy that goes on at the Federal Trade Commission. I am appalled


    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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