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    Have you ever been minding your own business when suddenly, out of nowhere someone contacts you and unexpectedly burst into a fit, demanding that you do something you have no idea what is and t
    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
    hen, because you can't give them this one thing, this person starts calling you names?

    The whole thing is so surrealist and seems so arbitrary that you don't even know how to react and when th
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e earthquake is over--because this is what you feel is happening-- and you can breathe again, you ask yourself: What on earth was that?

    Here is an example: you are having a great time during 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.

    e weekend, enjoying your friends who came over to visit, sharing good food, good wine, and good conversation, listening to great music, relaxing and feeling fantastic, so well deserving of this
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    great time you are having.

    Or perhaps you are happily watching a movie or a football game on TV or reading a good book, or writing a letter to a loved one. Or, perhaps you are playing with yo
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    r children; perhaps you playing your saxophone, perhaps you are taking an aromatic bath; perhaps you are cuddling with your lover; perhaps you are doing business, perhaps... and the phone rings
    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
    .

    You let the machine pick it up but then decide to answer the call anyway.

    On the other line there is a person whom, out of the blue, starts blaming you for not corresponding to some expecta
    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
    tions they had from you and you, taken aback start to justify your actions and apologize as if you were in a court martial or something and needed to prove your innocence.

    Then, feeling that y
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    u must appease this person you ask for a resolution and they, instead, start to offend you and call you names. Now you are thinking that you should not take the abuse and politely end the call
    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
    (or perhaps not so politely). You then become aware that a nasty rain just befell upon you and think: Gosh, what was this all about?

    You become angry and your heart beats faster and your thoug
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ts race, and your feelings are all over the place. You know you lost your cool and that relaxed time you were having before the call is gone. You think: what have I done?

    You try to understand
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    what on earth just happened but you find no rhyme or reason. And then, because you subscribe to the Law of Attraction, you think: what was I thinking to attract this to my life today?

    You fee
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    l miserable and try to look into yourself to determine what caused such strange behavior. You can’t fathom how you indeed have attracted this nonsense into your life. You are mad and no matter
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ow much you know it is up to you to forgive, you don’t want to. You feel abused, and justly so.

    So what do you do to get out of that angry, unforgiving mode? Here are some ideas for you:

    1. R
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ealize that you cannot please everyone all the time. You will always find someone who, not based on real facts, complains about you no matter what you do.

    2. Realize that there are things you
    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
    an give and others you can’t. If another person demands what you cannot do, just let go; move along.

    3. Understand that you need to trust that everything is just what it is supposed to be. The
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    re is perfection in the universe. What is not and those who are not, perfect, will leave you, sooner or later. Have faith.

    4. Know that some people are really unreasonably bitchy and this has
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nothing to do with you; some are also very mean. It is their nature. Let them go as there is nothing you can do about it and you certainly don’t want them in your life.

    5. When you are by your
    .

    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
    elf, take a deep breath and exclaim: The hell with you! And then bless this person as they can’t help but be a nuisance.

    That will make you feel so much better that you can go back to what you
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    were doing before the earthquake and enjoy the rest of your day. And do as Scarlet O’Hara: "I will think about this tomorrow!"

    And when tomorrow comes, you say it again. There! Problem solved


    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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