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    There are two ways to do business in a city or town in the United States. You can go with the flow and work with the establishment or your can take your entrepreneurial talents, hard headedness and will a
    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
    nd ram it up their ass. What do you mean you ask?

    Well lets take any city in the US for instance, there are folks in business, good ole’ boy networks established and they work hard to make sure they get
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    he juice. It is the same way in Nationally run businesses with lobbyists, associations and political favors.

    Adam Smith warned us of this, it is not a new thing. It is pretty disgusting if you ask me. Yo
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    would think that companies with all the juice and power grew their businesses to that size by competing in hard fought markets and industries. But they grow old and tired and why work hard when you can p
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    y your government to run interference or run block from your competition so you can continually score goals. Why bother working hard if you don’t have too? Indeed, isn’t that human nature?

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

    Combination pro
    it has always been done, it is the reality and the way things are. If you think it is anything else you are full of shit. It is what it is and you will have to deal with it or risk being pummeled from ou
    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
    of the blue. Before you start a business you should probably check who your competition is, which clubs they belong too and who their friends and relatives are in a community. If they are too politically
    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
    connected you need to be extremely careful while risking your capital in a business.

    Let me tell you a story; You see when first starting out in business I was into car washing. And I found just such a c
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    mpetitor well connected in the city. Well it was an Owner of a carwash in Thousand Oaks CA in 1990. I had taken clientele from him due to better quality, lower prices and quite frankly better service. Alt
    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
    ough I must admit, as good as we were, the car wash owner was really no competition, the service was mediocre at best.

    When we did a car wash fundraiser across town he went to the city and complained abo
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t these kids polluting. He could not complain about us, we were helping for free. The wash water run-off never made it to a storm drain as it flowed into the grass. But that did not stop him from shutting
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    down the operation and immediately the code enforcement the next day came to our business and started going thru the book looking for something to get us on? As you know CA is always like WA, MA, MD and
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    L first to implement environmental legislation and CA is the worst state to do business in with all their over regulation on everything from ridiculous labor laws to fines for ascetics.

    The well-connecte
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    car wash owner gentleman’s name was Jack Galley and he is now dead. He was getting older and probably our competition and refusal to submit to his attacks finally killed him. So what, he cheated, and use
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    his connections and abuse of power to attack us, we were a great company back then, we deserved the customers, so screw him. As his health started to fail him he sold his car washes to Wash Depot, a car
    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
    ash consolidator, because he could not maintain volumes during illness and competition increasing in the area, mostly from us.

    During that time, I watched the local carwashes from fifty miles come togeth
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    r and form a small association and go after our company during a 2-year battle with City Hall, planning commission, council, city attorneys office, public works and court room. We finally won, in the med
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    a, courtroom, city hall and in the Market Place.

    We refused to give up, never give up. So suffice it to say; “You can go with the flow and work with the establishment or your can take your entrepreneuria
    .

    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
    talents, hard headedness and will and ram it up their ass!” We choose the second option. Most who try this lose. Personally I am not into losing. But I advise small business owners starting out, to be a
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ittle less hard hitting and go a little more with the flow.

    You see often “discretion is the better part of valor” but if you are forced to, sometimes you have to fight to be a man. Think on 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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