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  • Advice You - Stretching Your Sense of Service

    How far does your service go? And how much farther can you stretch it?
    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

    If you serve customers, do you stretch to do it better every day? 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
    ou eager to learn from colleagues and mentors, seminars, books, website
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    , and a healthy dose of candid customer feedback?

    If you provide inter
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    nal service, do you reach across functional lines, or stay stuck inside
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    your departmental 'silo'? Is your communication with colleagues and par
    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
    ners positive, proactive and persistent?

    If you serve in your communit
    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
    y, do you volunteer time and stretch a little more by asking others to
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    oin you?

    If you serve your family, do you reach out with a higher leve
    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
    of attention and affection every day?

    If you serve the planet, are yo
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ecologically aware? Do your actions inspire and educate the neighbors?
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a


    If you serve humanity, do you cultivate true compassion, patience, ki
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    dness, respect and encouragement of others?

    If you serve all life, hav
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    you expanded your sense of life itself and your understanding of what
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    it means, being here 'in service'?

    Key Learning Point

    Service is a gr
    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
    at line of work, and those of us who do it daily are certainly among th
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    fortunate on Earth. You can increase your good fortune, and that of ot
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    hers, by deepening your commitment and expanding the impact of your ser
    .

    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
    ice every day.

    Action Steps

    Make an extra effort to s-t-r-e-t-c-h you
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    sense of service. Each day, offer a little more than you did yesterday


    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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