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    “Will you marry me?” That was the most important question I ever asked anyone in my life. I was ver
    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
    y fortunate when Rika finally agreed! I have the best wife in the world, no question about that, bu
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    t it would never have happened had I not asked. March 29th, we’ll have been married for 20 years. A
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    l because I asked. How many opportunities have we lost in life, simply because we didn’t ask? What’
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    s the worst that can happen? They can say, “No.”

    I know it’s hard for some of us to ask, especiall
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    self-sufficient, proud, responsible, disciplined and hard working entrepreneurs. We don’t want to
    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
    take advantage, we’re afraid of being made a fool of, afraid of rejection, and so on. But the fact
    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
    s, things only happen when we make them happen. And that usually involves asking people to do somet
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    hing. Together, we can do amazing things – but we need to invite others to participate in our Joint
    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
    Venture programs in order to achieve the maximum results, and that involves asking. And it’s absolu
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    tely amazing what people will do, if you simply ask them to!

    I talked with a beggar on the street
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    once. I was interested to know if he felt bad when people didn’t give him money. He answered, “No,
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    iree! I don’t feel bad if they ignore me or don’t give me money – THEY feel bad! I just keep on ask
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    in’, askin’, askin’, and the Law of Averages kicks in. I can predict pretty accurately how much mon
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    y I will make on any given day, as long as I keep askin’. And the more I ask, the more I git!” Sale
    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
    speople know this – it’s a Numbers Game – ratios are real. Statistics are real. It’s a game. Ask te
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    people and you might get something. Ask a thousand people and you most certainly will!

    Set up you
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    r Joint Ventures in such a way that YOU ask many people and that you have a system to ask many more
    .

    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
    And the more you ask for, the more you’re likely to get. Be confident, plan your strategy well and
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ASK. By all means ask. Ask many people. Ask for more. “You have not, because you ask not”, is true


    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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