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    There are times in business when you need to walk away from a deal. This i
    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
    s a tough thing to do. I hate doing it. It takes money out of people’s po
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    kets and it makes me sick to my stomach – but sometimes you have to do it 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.

    o be successful. Here are three times when it may be best to walk away fro
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    a piece of business:

    When it compromises your integrity. If you h
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ave to do something that will make you feel dishonest, unethical or immoral
    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 get the business or to fulfill you agreement, you should walk away. In
    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
    the end a person’s character is demonstrated by what he does when nobody is
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    looking. If you don’t feel good about it, you should not do it.

    When y
    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
    ou sacrifice the long-term potential for a short-term gain. If you nee
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    to mortgage your future for the instant gratification of an immediate deal
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    , you should walk away. Business strategy is about playing the “long game”
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    that is developing relationships that last. A short-term solution that dam
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ages a long-term relationship is bad business.

    When you question the in
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    entions of the other party involved in the deal. If you think the other
    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
    party is “up to no good” or setting you up for failure you should walk awa
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    . If you know that the other party is out to harm you and you move forward,
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    you are asking for trouble.

    Walking away from business is horrible. It i
    .

    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
    a rare thing. The best thing you can do is set your guiding principles (t
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    hings that you won’t compromise, such as the items above) and stick to them


    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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