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    It was early evening late in March, 2004 when my office telephone rang. When I picked up the receiver it was a young man with whom I w
    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
    as involved in times past in network marketing businesses. I knew by instinct why he was 1calling me, and I didn't want any part of a
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    nother network marketing business. I had failed often enough, but my mother raised me right, and I didn't hang up on him.

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

    alf listening to him when he said his product was liquid. That made me sit up and take notice. I absolutely did not like liquids. As a
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    child when I had a cold the doctor had to prescribe cough medicine in pill form. My caller further told me it was not selling, but
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    as a marketing opportunity. Thinking of a way to get rid of him without being rude I said "Marc, you know I can't market anything un
    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
    less I believe in it." Whereupon he said "Let me send you a bottle, then you can make up your own mind."

    Sooner than I expected, the
    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
    sample bottle arrived. I took note the company name was XanGo. I noticed the bottle was attractive. I read the contents - nothing un
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    sual about the contents, but what in the world was 'garcina mangostana'? My first reaction - I had better taste it. That was the lea
    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
    st I could do, after Marc was nice enough to send it. I opened the bottle, put a generous portion in a drinking glass, and downed it.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    y immediate reaction - not too bad.

    Marc had sent me his website so I went to the computer and read

    the site. Impressive! He had inc
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    luded a newsletter and a couple brochures. I absorbed them.

    But then my common sense came to the forefront. It seemed like a

    good id
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ea, but I only had enough money left from my social security check to pay my electric bill and telephone bill. How did I think I could
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    afford to get involved in a network marketing business?

    I thought about the business all weekend. I have always been a spontaneous
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    person, but I lived alone and had nobody to talk over the possible pitfalls that might occur. Finally I went to Marc's website and
    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
    signed up as a distributor. The next day Marc found out he had another downline. But all was not well.

    Marc was so sure I wouldn't bu
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ild the business he kept my sponsorship

    but he placed me under somebody else. He told me the person's name and telephone number and s
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    uggested I call him, which I did, but he never returned my call. Did that endear me to him? Absolutely not! Did I call him again? No,
    .

    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
    I did not.

    I can be stubborn. I'm old enough to be Marc's mother. Silently I thought to myself - where's that young whippersnapper g
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    et off, telling me what to do? Did I make any money? Read on to find out how things turned around for me after I got off my high hors


    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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