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  • Summary - Kick-Start Your Love Life!

    No matter how many years you have been together as a couple, your relationship deserves the same kind of attention it receive
    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
    d at the beginning. Surprisingly, this is often not the case in many relationships. Just as starting a new relationship requi
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    res effort, so does maintaining a successful one. Unfortunately, many forget that when their relationship ends and they go to
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    start a new one, they’re going to have to put in the effort then. The question is, "Why not now?"

    I remember my first marri
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    age. We had been a couple for seventeen years. Unfortunately, our relationship lacked in the romance department. Despite many
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    attempts and pleas on my part, I could pretty much count the number of dates we had on my two hands. Suffice it to say, lone
    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
    liness and resentment inevitably consumed the relationship and our marriage ended.

    I often hear similar stories from clients
    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
    , colleagues, and friends, saddened that their relationship has little or no zest. However, before we go and point the finger
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    at our partner, we need to first ask ourselves if we’ve really made a conscious effort to do our part. Have we voiced our co
    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
    ncerns to our partner? Have we been clear and specific about what we want? Did we approach our partner lovingly without blame
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ? Or are we basing our disappointment and frustration on assumptions we’ve made—that our mate should know better since, of co
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    urse, we already do ... or do we?

    Here’s another question that stops some people dead in their tracks. When was the last tim
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e you asked your partner out on a date? This goes for the ladies too. Dating, you ask? Isn’t that something you do before you
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    move in together? As my teenaged daughter would say, "Not!" And if your partner declined your warm invitation, did you happe
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    n to ask your partner out again? Many lament, "But I’ve already tried." I invite you to heed the words of wisdom from Yoda, t
    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
    he green pint-sized creature in Star Wars: "There is no try, there is only do," and do and do.

    Dating is not about putting y
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    our partner first, but your relationship. It is an excellent means and opportunity for the two of you to discover each other
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    anew, rekindle the flame, and grow closer together. Someone’s got to get the ball rolling, so why not you? And hey, did you k
    .

    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
    now that May is "Date Your Mate Month"? What a perfect lead in to ask your honey out on a date!

    Take action now! Kick-start
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    your love life! You and your partner deserve it! Always remember, the reason you’re together as a couple is because you dated


    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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