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    Years ago I learned a lesson about writing that has stayed with me down through the years. Perhaps what I learned then can help you now. Back
    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
    then as an inexperienced advertising copywriter, here is how one of my bosses taught me to write.

    At the time, I was trying to learn how to be
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ome an advertising sales letter copywriter. Each day, at my job, I would be given assignments to write one or more sales letters and attached t
    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 assignment there was always an urgent due date – a deadline. So, each morning I sat down at my typewriter (this was before computers) and
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    got to work typing the sales letter that was the most urgently needed. Of course, my circular file (the wastebasket) soon filled with crumpled
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    sheets of paper that were my failed attempts to write the perfect sales letter I needed that day.

    One day my boss, whose office was right nex
    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
    to mine, walked over to my doorway and said: "Terry, stop typing! Now listen to me. Here is the way I want you to work every day from now on
    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


    First, lean back in your chair, and second, prop your feet up on that desk! Third, swing around and look out the window. Now, fourth, mental
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    y, I want you to put on your thinking cap and, fifth, think about what you are going to write.” Then, still in all seriousness, but with a smi
    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
    le on his face, he continued: “ If I hear that typewriter of yours clicking anytime between 9am and 3pm any day of the week from now on - you w
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ll be fired!

    "Then,” he quietly continued: “after you spend most of the day thinking you can put your feet on the floor, move to your typewrit
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    r, and spend your next hour writing. Believe me”, he said ” that is the only way you can write the kind of sales letters I will approve! With
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    smile, he then asked: “Why do I say this? Because, by the late afternoon, I know you will have thought the problem through and understand eno
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ugh so what you write and hand to me for approval, will be very good!"

    Of course, I did what he said and - It worked! I kept my job there and
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    y writing (and thinking) got better and better each day. But, I have to say this: by the end of each day thereafter, as I dragged myself home,
    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
    was physically and mentally exhausted!

    Believe me when I say digging ditches all day long would have been much easier work! Obviously, the l
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    sson I learned back then was this: thinking is the hard work that makes writing easy!

    So, the next time you need to write something or solve
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    an important problem, perhaps you should put on one of my imaginary thinking caps, see for yourself how it can serve as a practical reminder th
    .

    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
    t will force you to focus all of your attention on the fact that you need to think first and write later.

    P.S. If you want a real Weber think
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ng cap to help you, you can order one on my website: http://www.originalsbyweber.com


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