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  • E-Folder - Well Then, Who Do You Do It For?

    I enjoy high-end music systems in my home and office.

    One day I called
    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
    the dealer to order extra CD cartridges, wanting to pre-load them with
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    different music. He was out of stock, but said more were coming soon.
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.


    ‘Great!’, I replied, ‘Could you give me a call as soon as they come in
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ?’

    He was reluctant. ‘They’ll be coming in a few weeks. Why don’t you
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    call us back then?’

    With my travel schedule, I imagined missing the ne
    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
    xt shipment and asked again if he would call me. I reminded him that I
    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
    had purchased $7,000 of equipment from his shop.

    When I mentioned my a
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ddress, he replied, ‘I remember you. Well, as a personal favor, I’ll tr
    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
    y to give you a call, but we don’t usually do this for customers.’

    I w
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    s stunned. If not for customers, who do they do it for?

    Key Learning P
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    oint

    Quick outbursts from employees often reveal the real mindset lurk
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ing behind a surface smile. Have you ever heard someone say:

    `We can't
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    do that for you. It's not our policy. I'd like to help you, but it's
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    not my department. You have to speak to someone else.'

    Remember, servi
    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
    ng customers is why you go to work. If your customers disappear, your p
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ositive future may vanish, too.

    Action Steps

    Listen for phrases that
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    reveal a mindset of `I just can't be bothered.' Identify them, then eli
    .

    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
    minate them.

    When you shop, keep your ears well tuned. If they don't t
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ruly want to serve you well, take your precious business somewhere else


    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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