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  • Cases - We Are Really Sorry For You, But...

    I lost my mobile telephone. The telephone company told me to file a police repor
    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
    t and then come down to their office to buy a new phone.

    When I arrived, the co
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    unter staff member was helpful and understanding. She gave me a discount on my n
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ew phone purchase and a free replacement SIM card holding my personal account de
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    tails. I was pleased and grateful.

    Five months later I lost my handphone again!
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    This time I knew what to do. I filed a new police report and went back to the c
    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
    ompany to buy a new phone.

    The counter staff member was helpful and understandi
    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
    ng, but she gave me neither a discount on the new phone nor a free replacement S
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    IM card. I asked if she had forgotten, or if the company policy had changed.

    Sh
    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
    e replied, ‘We are very sorry that you lost the phone, and our policy is to give
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    a discount and a free SIM card to make things a little easier for you. But our
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    records show you lost your phone five months ago, and we can only feel sorry for
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    you once a year.’


    Key Learning Point
    -----------------------------
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ---------------------------------------------------
    Generosity is a good se
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    rvice policy whenever your customers need help. If they need help twice, be gene
    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
    rous twice. (No one loses their mobile phone twice on purpose.)


    Action St
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    eps
    -----------------------------------------------------------------------
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ---------
    Look for situations where your company policy restricts the flow
    .

    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
    of generosity towards customers who have a problem. Change the policy. Don't hol
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    d back. Give generously when customers need you. Over time they will reward 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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