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  • Answers - Tax Time -- Life Time

    April 15th has come and gone and with it the tax season – at least for most people. I don’t know about you but I needed that two-day grace period. I can always use a little extra time. Think about it. Tax day happens at th
    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
    e same time every year. Some people are so prepared and organized they are ready before the deadline. Thousands more, however, procrastinate. In fact so many procrastinate that they stand in line with hundreds more just to
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ut their tax forms into the mail at the eleventh hour…or should I say the 24th hour. Other folks wait so long that they have to file an extension just to give them “time” to pull things together.

    For the first time in 15 yea
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rs I decided to do my own taxes. I guess I just got tired of paying someone to type in all of my numbers into a computer program that would automatically generate my return and tell me how much I had to pay to Uncle Sam. I f
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    gured I could do that myself – for free. I have to admit though, that I still have a little anxiety about whether or not I inputted the numbers correctly.

    Tax time kind of reminds me of how we sometimes approach life – actua
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    lly, it may even be an extension of it. For instance, take a look at how some of the following tax attitudes mirror some of our attitudes of life.

    Tax Statement: “I hope I have all the numbers where they need to go on my ta
    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
    form.”

    Life Statement: “I hope I’m doing things right so that right things will happen.”

    Just as it doesn’t pay (literally) to blindly and randomly input numbers into your tax form, it makes no sense to live life randomly
    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 no purpose or direction. It pays to do your homework. There is an old carpentry proverb that advises us to “measure twice and cut once.” That, of course, would be in contrast to measure once and cut twice. You get the
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    point. Sometimes we too quickly make decisions without considering the consequences. Hope is a wonderful quality of life. But to have quality in life, knowing the facts can make a difference in whether or not our hopes come
    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
    true.

    Tax Statement: “I will wait until the last minute so that the government doesn’t get any more than what’s coming to them.” Life Statement: “I am going to hang on to what I have for as long as I can.”

    While me may
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    grouse and complain about how it doesn’t pay to pay taxes (questionable statement at best), it does pay to be generous. There are so many needs all around us that need our attention. When our lives come to an end, what we ha
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e banked, stored, saved, and horded will not do us any good at all. The best thing to do with our stuff when we stop living is to give it away so we keep living through how we help others live.

    Tax Statement: “I will just f
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ile and extension.”

    Life Statement: “I can do this later”

    When I was a kid I remember a Garfield (you know, the orange cat with an attitude) poster with a sarcastic saying that went something like this: “I am going to stop
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    procrastinating and I think I will start tomorrow.” Right now, as these words pass through your eyes and into your brain you know there is something that you have been putting off. It may be as simple as balancing your check
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    book and as serious as apologizing to someone for a grievous act you committed against them. It may mean putting your fears aside and making a decision to start that new business venture. It may be asking the girl of your dr
    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
    ams to marry you.

    Here’s the difference between the tax statement and the life statement regarding procrastination: While the threat of the federal government to imprison you for not paying taxes is your main motivation to f
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ile each year, your only motivation to take action in your life is, well, you. However, the life outcome is similar to the tax outcome. If you choose not to take action you will go to prison. But in this case it will be the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    prison of “would have, could have, should have.” Many people are living a life sentence. Decide today not to be one of them.

    We only get one chance to live the life we have been given. Let’s make the best of it. Decide to
    .

    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
    day to take three positive actions toward taking charge of your situation:

    1. Take time to do the research that will propel you into the most positive outcome

    2. Make a decision today to give something away. Your money, you
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    time, your love, your friendship, your talents. Find something that means something to you and let it mean something to someone else.

    3. Refuse to allow fear to keep you from making your dreams come true. Take action today


    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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