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  • Advice You - E-mail Misunderstanding? Take Time to Cool Off!

    Misunderstandings abound in e-mail. Many times simply due to one side
    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
    not taking the time to ensure that their message and intent is clear, w
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    hile the other side reads into the e-mail things that may not be there.
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.


    That is why it is always so important if you get an e-mail that upsets
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    you to:

    • First, take the words at face value and don't assume
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    anything. If you are not sure of intent or the tone relayed, ask for 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
    larification before you spend the energy being upset and snapping back
    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
    with an emotional response.

  • Then, take a deep breath. If yo
  • nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    are sure the other side is purposefully trying to be upsetting or rude
    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
    , wait until the next day, if at all, to reply. Many times rude and ma
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    icious e-mailers do not deserve a response. Just leave those who can o
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nly communicate by being nasty wallowing in their wait for a response f
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    rom you that will never come.

    A great majority of misunders
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    andings are because one side didn't realize how the words they chose an
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    d how they chose to write them (formatting, bolding, red text, caps, et
    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
    .) may be taken based on the relationship dynamics with the person on t
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    he other side of the screen.

    The best rule of thumb is to take time to
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    cool off. Typing out an emotional reply never solves anything. You m
    .

    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
    y be surprised how you will have a different point of view when you rev
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    iew the e-mail the next day to determine even if it is worth a response


    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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