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  • Answers - How Secure Are You?

    The idea of the "American Dream" has changed significantly over the last few decades. The age old "land of oppor
    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
    tunity" has morphed into "give me security". People raised in this country have begun to take for granted the tr
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e opportunities that still exist, and choose to find comfort and alleged security with their careers. They still
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    have a dream of prosperity, but feel that they simply deserve it with out taking the significant risks involved i
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    having true prosperity.

    The middle class ideal is the cush corporate job with all the perks. We want 40 hour w
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rk weeks with 4 weeks of vacation. Throw in a 401k and health insurance to give us the feeling that our future 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
    ll be safe. How safe is it? Reality is that corporations are subject to the almighty dollar. A few bad quarter
    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
    , a few bad decisions by some one above you and all of the sudden, you are expendable. The illusion they gave yo
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    when you took the job can end at any time by the whim of people in "Ivory Towers". As an employee of a Fortune
    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
    00 company, I have now found myself in this position. A job I felt would carry me to the "Happy Golfing" years,
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    as melted in front of my eyes before I turned 35.

    What is true security? Does it exist in today's society? If
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    your honest with yourself, you will discover that nothing is secure in this world. Every decision we make can ha
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e negative consequences. Any idea that leads to prosperity involves an amount of risk. I hear Americans complai
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    about being stagnant and under paid, yet they will not put anything at risk to break out into the opportunities
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    hat pass them every day. We want it to fall into our laps and even worse, we feel some how we deserve it to.

    Ou
    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
    country has not lost its "Dream". In fact the opportunities are more numerous than ever. A quick search of the
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    internet, newspapers, and advertising will reveal a world of possibilities to start your own business and find yo
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    r own security. The problem? It takes an amount of risk. The solution? Every day is a risk. Why not put your
    .

    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
    elf in a situation that will produce true prosperity? I encourage you to expand your horizons into the world of
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    deas. Let your ideas and skills bring you what you are truly worth. Do not let others place your worth upon you


    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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