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  • Useful Advices - Saying No to Customers

    It happened again, just the other day. Someone called, ready to
    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
    order a product from me--and I talked her out of it. Does that
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    sound crazy to you? Maybe it is, but I think it is a good busin
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ss practice, and it is the honest and ethical thing to do in so
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    e circumstances.

    In this case, the product she called about wa
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    n't right for her. I would rather not make that sale than have
    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
    customer who is unhappy with her choice to buy from me. Will s
    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
    e return and buy something else someday? Maybe. And if she does
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    she knows that I will be looking out for her best interests--n
    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
    t just to make the sale.

    Although I don't want to give the imp
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ession that this happens all the time, it has happened before.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ometimes I recommend an alternative product or service, such as
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    suggesting that a class might be more beneficial than a consult
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    tion. Other times, simply offering honest answers and informati
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    n helps the customer decide whether or not a purchase is right
    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
    or them. I won't refuse to sell to a customer, but I will alway
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    be honest with them.

    What reputation do you want to have--tha
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    of the person who will sell anything to anyone, or the person
    .

    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
    ho will make an honest effort to best meet the needs of your cu
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    tomers (even if that sometimes means not making the sale today)


    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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