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    2006. When I was a kid growing up thinking of the year 2006 was like dreaming
    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
    about living in Star Trek times. And in some ways, compared to the 60's we are
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    living in Star Trek times. Personal computers, PDAs, cell phones, DVDs, iPods,
    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 internet, broadband and other great technologies were only a dream back th
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    n. Heck, even some old technologies like color TV, cassette tapes and VHS reco
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rders were far from being incorporated into our daily lives. In some ways we w
    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
    re living in the stone age compared to today.

    But all of these new technologi
    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
    s have come at a price to the small business owner and high level manager. We
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    eed to be connected all the time. People need to be able to reach us via phone
    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
    . We must produce more and more every year. We must be able to multitask. How
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    an we do it all?

    Organization! That is the key. We must be organized at all t
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    mes. We must be able to deal with all of the email and paperwork that hits our
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    desk. We must know where we are supposed to be and with whom we are supposed t
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    o be in contact. Missing appointments and letting business fall through the cr
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    cks is a no-no.

    Do you have a system of organization? Is your contact databas
    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
    up to date? Is your calendar clean? Can you handle the hundreds of emails you
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    receive each week or do you do a mass deletion when your in-box gets too full?
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    Can you process the paper that hits your desk or do you have stacks of paper
    .

    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
    ll around your office or work area? These are a few questions to consider as y
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    u start the new year with intentions of making it the most productive year yet


    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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