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    Just the other day I saw a t-shirt that said:

    "My anger managemen
    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 class pissed me off."

    Learning to or having to manage your ange
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    can be no fun.

    A wake up call

    You get angry, I get angry
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    all God's children get angry. It's what we do with our anger that
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    makes all the difference.

    Our children can be wonderfully humblin
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    mirrors.

    After a prolonged temper tantrum resulted in our son mi
    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
    ssing out on a fun event, I actually heard this coming out of my m
    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
    uth:

    “When you decide to stay angry you can miss out on a lot of
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ood stuff.”

    A true case of the pot calling the kettle black.

    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
    ow to stay angry



    • Focus on the event that made you a
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    gry by playing it over and over again in your head.

  • Focu
  • ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    s on the injustice of it all.

  • Tell lots of people about
  • dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    t until you find someone that completely agrees with you.

    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    >Refuse to accept any responsibility for the situation or look at
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    our part or contribution.



    How to move past anger
    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
    >



    • Feel the anger and then let it go.


    • Get it t
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    hat life is not fair and never will be

  • Take responsibili
  • y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    y for your part in the situation.

  • Consider what you can
  • .

    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
    egitimately do about the situation, do it, and then move on.
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip


    Staying angry or moving on to the good stuff is your choice


    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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