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    Have you found that when you’re uptight about something, tired, hungry and stressed, that you tend, ever so slightly, to overreact sometime
    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
    s? I received a nasty e mail the other day accusing me of spamming this person (who had subscribed / opted in to my ezine, by the way). Obv
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    iously, he was having a bad day and had lost perspective on spam. I sent him a note which I thought I’d share with you, just so we can main
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    tain perspective in this busy day and age.

    First of all, I receive over 360 spam e mails a day. That’s the price one pays for a strong Int
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    rnet presence, I guess. I don’t use a spam filter as it has cost me money in the past by blocking important e mails. (Spam filters have no
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    brains, you see; they’re simply robots.) Here’s the thing – it takes me a total of 12 minutes to delete the spam, but I save hours every da
    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
    y using the Internet and e mail. TWELVE MINUTES. Let’s see that in perspective. How long do you wait for your food in a restaurant? How muc
    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
    h time do you spend commuting? I don’t spend hours attacking the spammers - I simply hit “Delete” and move on.

    Also, there are different t
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    pes of spam – helpful, uplifting information and valuable offers on the one hand, and sleazy porn and scammers on the other. Either way, it
    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
    takes two seconds to delete. So, when one looks at the real time usage compared to the benefits, why do people react so violently to what
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    they perceive as spam? Why the threats and why take so much MORE time to write to the “spammer”, instead of taking two seconds to delete th
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e e mail? Is there perhaps something else going on here?

    There’s the rub! The REAL reason, I suspect, why people get so angry at certain “
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    pam” e mails, is that their buttons are being pushed. Something in that e mail reminds them about something about themselves that they’re n
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ot happy about. They look in the mirror, don’t like what they see, and smash the mirror. “You can break the scales, but you’ll still be fat
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    .” They shoot the messenger when the message is a little too close to the truth. Instead of standing back and asking themselves, “Why am I
    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
    reacting so violently? Is there a message here for me? What can I learn from this?” they attack. Anger often comes from fear. Perhaps we sh
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    uld start reading some of those really irritating e-mails.

    There’s a radio station here that spouts the worst kind of socialism, anti-esta
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    blishment collectivism and everything that is directly opposed to my philosophy. And I LOVE listening to it. I learn so much. It gives me p
    .

    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
    erspective, corrects some of my assumptions and strengthens others. There are some very smart people on that show – much smarter than me! P
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    erhaps we should be less threatened and more open minded about spam and look at the upside of this amazing, time-saving thing called e-mail


    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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